Trial Outcomes & Findings for Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NCT NCT00592293)

NCT ID: NCT00592293

Last Updated: 2025-07-03

Results Overview

Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur \> 90 days following completion of radiation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

5 years from the completion of radiation treatment

Results posted on

2025-07-03

Participant Flow

Participant milestones

Participant milestones
Measure
Proton Beam Radiation
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Overall Study
STARTED
70
Overall Study
COMPLETED
69
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Proton Beam Radiation
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

Proton Radiation for the Treatment of Pediatric Bone and Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Proton Beam Radiation
n=70 Participants
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Age, Continuous
12.8 years
n=5 Participants
Sex: Female, Male
Female
28 Participants
n=5 Participants
Sex: Female, Male
Male
42 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
Race (NIH/OMB)
White
60 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
Region of Enrollment
United States
70 participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 years from the completion of radiation treatment

Cumulative incidence (percent of participants and 95% confidence intervals) who experienced a grade 3, 4, or 5 late toxicity. Late complications are defined as the delayed effects attributable to radiation which occur \> 90 days following completion of radiation.

Outcome measures

Outcome measures
Measure
Proton Beam Radiation
n=70 Participants
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Cumulative Incidence (Estimated Percentage of Participants) Who Developed Toxicities Following Radiation Treatment
17.7 percentage of participants
Interval 9.7 to 28.8

PRIMARY outcome

Timeframe: 5 years from the start of radiation treatment

Rates of local control using proton radiotherapy. Local control is the lack of tumor recurrence in and or near the area where the primary tumor occurred.

Outcome measures

Outcome measures
Measure
Proton Beam Radiation
n=70 Participants
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Local Control
87.1 percentage of participants
Interval 78.1 to 93.7

SECONDARY outcome

Timeframe: 5 years

Population: Data were not collected and this outcome was not analyzed. DVH's were not generated for these patients. Data will not be collected in the future. The decision not to generate photon/proton contours DVH's was at the discretion of the dosimetrist/treating physician.

Comparison of Dose distribution to tumor and surrounding normal structures using Dose-Volume Histograms (DVH) generated from the proton plan used to treat the patient and the photon plan generated for comparison purposes.

Outcome measures

Outcome data not reported

Adverse Events

Proton Beam Radiation

Serious events: 8 serious events
Other events: 69 other events
Deaths: 17 deaths

Serious adverse events

Serious adverse events
Measure
Proton Beam Radiation
n=69 participants at risk
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Blood and lymphatic system disorders
Myelodysplastic Syndrome (MDS)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Hepatobiliary disorders
Venoocclusive disease
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations
Staphylocaccus bacteremia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia (AML)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Small Bowel Obstruction
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders
Anorexia
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Leukopenia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Neutropenia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Lymphopenia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Investigations
Platelet count decreased
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Subglottic stenosis, tracheotomy
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Febrile Neutropenia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders
Dehydration
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

Other adverse events

Other adverse events
Measure
Proton Beam Radiation
n=69 participants at risk
Proton Beam Radiation Proton Beam Radiation: Once per day, 5 days a week for a total of 4 to 6 weeks.
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Hearing w/o audiogr not in monitor prg
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Hearing w/w-o audiogr in monitor prg
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Hearing-other
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Otitis, external ear (non-infectious)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Otitis, middle ear (non-infectious)
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Tinnitus
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Hemoglobin
37.7%
26/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Leukocytes
43.5%
30/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Lymphopenia
43.5%
30/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Neutrophils
42.0%
29/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Blood and lymphatic system disorders
Platelets
39.1%
27/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Fatigue
79.7%
55/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Fever w/o neutropenia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Sweating
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Alopecia
18.8%
13/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Bruising
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Dry skin
10.1%
7/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Erythema multiforme
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Hyperpigmentation
31.9%
22/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Hypopigmentation
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Induration/fibrosis
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Pruritus/itching
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Radiation dermatitis
94.2%
65/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Rash/desquamation
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Skin-other
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Telangiectasia
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Wound - non-infectious
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
ACTH deficiency
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
Adrenal insufficiency
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
Endocrine-other
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
Gonadotropin secretion abnormality
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
Growth hormone secretion abnormality
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
Hot flashes
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Endocrine disorders
Hypothyroidism
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Anorexia
36.2%
25/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Constipation
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Dehydration
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Diarrhea w/o prior colostomy
10.1%
7/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Dry mouth
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Dyspepsia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Dysphagia
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Esophagitis
10.1%
7/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
GI-other
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Muco/stomatitis (symptom) pharynx
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Muco/stomatitis by exam, oral cavity
15.9%
11/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Muco/stomatitis by exam, pharynx
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Nausea
15.9%
11/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Obstruction, small bowel NOS
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Salivary
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Stenosis (incl anastomotic) pharynx
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Taste disturbance
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Teeth
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Teeth development
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Vomiting
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Growth velocity reduction
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Short stature
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Spine kyphosis/lordosis
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Hemorrhage-other
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Nose, hemorrhage
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Petechiae
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Pharynx, hemorrhage
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations
Infection w/ unk ANC sinus
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations
Infection w/ unk ANC skin (cellulitis)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Infections and infestations
Infection-other
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders
AST, SGOT
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders
Bilirubin
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Metabolism and nutrition disorders
Hyponatremia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Bone: spine-scoliosis
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Cervical spine-range of motion
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Extremity upper (function)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Extremity-lower (gait/walking)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Fibrosis-cosmesis
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Fibrosis-deep connective tissue
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Fracture
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Joint-function
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Lumbar spine-range of motion
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Muscular/skeletal hypoplasia
14.5%
10/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
24.6%
17/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Nonneuropathic generalized weakness
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Nonneuropathic left-side muscle weak
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Nonneuropathic upper extr muscle weak
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Osteoporosis
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Trismus
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders
Agitation
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders
Cognitive disturbance
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders
Depression
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders
Memory impairment
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders
Neurologic-other
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders
Neuropathy-motor
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders
Neuropathy-sensory
10.1%
7/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Psychiatric disorders
Speech impairment
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Cataract
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Dry eye syndrome
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Eyelid dysfunction
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Glaucoma
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Keratitis
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Ocular-other
10.1%
7/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Optic disc edema
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Tearing
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Vision-blurred
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Vision-photophobia
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Skin, pain
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Throat/pharynx/larynx, pain
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Aspiration
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Atelectasis
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Cough
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Dyspnea
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Edema, larynx
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
FEV1
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reaction
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Obstruction, airway-pharynx
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
11.6%
8/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders
Bladder spasms
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders
Cystitis
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders
Incontinence urinary
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders
Obstruction-ureteral
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders
Renal/GU-other
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Renal and urinary disorders
Urinary frequency/urgency
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders
Irregular menses
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders
Libido
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders
Sexual/Reproductive function-Other
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Vascular disorders
Thrombosis/thrombus/embolism
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Vascular disorders
Vascular-Other (Specify)
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Edema head and neck
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Edema limb
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Lymphatics-other
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Abdomen, pain
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Back, pain
17.4%
12/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Buttock, pain
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Dental/teeth/peridontal, pain
4.3%
3/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
External ear, pain
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Extremity-limb, pain
5.8%
4/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Eye disorders
Eye, pain
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Face, pain
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Nervous system disorders
Head/headache
10.1%
7/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Ear and labyrinth disorders
Middle ear, pain
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Musculoskeletal and connective tissue disorders
Neck, pain
2.9%
2/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Oral cavity, pain
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Gastrointestinal disorders
Oral gums, pain
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
General disorders
Pain-other
11.6%
8/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Reproductive system and breast disorders
Pelvic, pain
7.2%
5/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Scalp, pain
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Skin and subcutaneous tissue disorders
Skin, pain
1.4%
1/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.
Respiratory, thoracic and mediastinal disorders
Throat/pharynx/larynx, pain
8.7%
6/69 • Up to 5 years following the completion of treatment, mean of 9.1 years
Acute toxicity will be scored at weekly status check visits by the radiation oncology nurse or doctor. In addition, acute toxicity will be scored at least one time within the 3 months following completion of radiation therapy. Version 3.0. Late toxicity is to be scored on a yearly follow-up basis for at least five years. Toxicities and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0.

Additional Information

Torunn Yock, MD

Massachusetts General, Hospital

Phone: 6177262000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place