Trial Outcomes & Findings for Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma (NCT NCT02050919)

NCT ID: NCT02050919

Last Updated: 2022-03-21

Results Overview

Descriptive statistical analysis will be conducted. The proportion with 95% confidence interval will be summarized.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: Assessed at surgical resection
• Results posted on: 2022-03-21

Participant Flow

Participant milestones

Measure	Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sorafenib Tosylate, Combination Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With High-Risk Stage IIB-IV Soft Tissue Sarcoma

Baseline characteristics by cohort

Measure	Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed at surgical resection

Descriptive statistical analysis will be conducted. The proportion with 95% confidence interval will be summarized.

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Pathologic Response Rate, Defined as the Percentage of Participants With Greater Than or Equal to 95% Necrosis.

20 % of participants Interval 5.7 to 43.7

SECONDARY outcome

Timeframe: Up to 5 years

Measured as the number of Grade 3-4 Adverse Events, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Number of Grade 3-4 Adverse Events

86 Grade 3-4 Adverse Events

SECONDARY outcome

Timeframe: At least 120 days

Population: Patients who had surgery.

Wound complication rate, including 1) any secondary operation for wound repair, or 2) wound management without secondary operation including invasive procedures without general or regional anesthesia, readmission for wound care, or persistent deep packing for 120 days or longer.

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Number of Participants With Wound Complications

10 Participants

SECONDARY outcome

Timeframe: Time from registration until death from any cause

Percentage of patients alive at 2 years, Method of Kaplan-Meier used.

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Overall Survival at 2 Years

82 percentage of patients Interval 54.0 to 94.0

SECONDARY outcome

Timeframe: Time from surgical resection to local recurrence, distant metastatic disease, or death, whichever occurs first, assessed up to 2 years

Population: 15 of the 20 patients enrolled on the trial were evaluable for DFS. Four patients were metastatic at baseline, and 1 developed metastatic disease during preoperative treatment.

Time from surgical resection to local recurrence, distant metastatic disease or death, subjects with stage IV disease excluded. Method of Kaplan-Meier \used.

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=15 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Overall Disease-free Survival (Stage IIB-III Patients)

13.3 Months Interval 6.0 to There were not sufficient events to define the upper limit of the confidence interval.

SECONDARY outcome

Timeframe: Time from registration until development of distant metastatic disease or death, whichever occurs first, assessed up to 2 years

Population: Four patients were metastatic at baseline, and thus excluded from the distant disease-free survival evaluation.

Time from registration to development of distant metastatic disease or death, subjects with stage IV disease excluded. Method of Kaplan-Meier used.

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=16 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Distant Disease-free Survival (Stage IIB-III Patients)

16.4 Months Interval 8.9 to There were not sufficient events to define the upper limit of the confidence interval.

SECONDARY outcome

Timeframe: Time from surgical resection until primary analysis ( Median follow-up for local recurrence 17.11 months, range 6.18 - 42.8 months)

Number of patients with local recurrence after surgical resection of the primary tumor

Outcome measures

Measure

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=16 Participants Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection

Number of Participants With Local Recurrence

0 Participants

Adverse Events

Treatment (Sorafenib, Chemotherapy, Radiation, Surgery)

Serious events: 18 serious events

Other events: 20 other events

Deaths: 5 deaths

Serious adverse events

Measure	Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 participants at risk Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
Infections and infestations Catheter Related infection	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Constipation	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Psychiatric disorders Delirium	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Diarrhea	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Encephalopathy	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations enterocolitis infectious	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Blood and lymphatic system disorders Febrile Neutropenia	60.0% 12/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypokalemia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Lymphocyte count decreased	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Neutrophil Count decreased	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Platelet Count Decreased	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations Sepsis	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations Soft tissue infection	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders syncope	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Injury, poisoning and procedural complications wound dehiscence	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations wound infection	35.0% 7/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.

Other adverse events

Measure	Treatment (Sorafenib, Chemotherapy, Radiation, Surgery) n=20 participants at risk Patients receive sorafenib tosylate PO QD on days 1-71 and 85-155, epirubicin hydrochloride IV over 3-5 minutes, and ifosfamide IV over 90 minutes on days 15-17, 36-38 (ifosfamide only), 57-59, 99-101, 120-122, and 141-143. Patients undergo EBRT on days 36-45 and surgical resection on day 78. Patients with positive margins, undergo EBRT boost on days 91-98. Epirubicin Hydrochloride: Given IV External Beam Radiation Therapy: Undergo EBRT Ifosfamide: Given IV Laboratory Biomarker Analysis: Correlative studies Sorafenib Tosylate: Given PO Therapeutic Conventional Surgery: Undergo surgical resection
Gastrointestinal disorders Abdominal Pain	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Activated partial thromboplastin time prolonged	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Renal and urinary disorders Acute Kidney Injury	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders akathisia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Alanine aminotransferase increased	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Alkaline phosphatase increased	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders alopecia	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders anal fistula	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Blood and lymphatic system disorders Anemia	95.0% 19/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations anorectal infection	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders anorexia	30.0% 6/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Psychiatric disorders anxiety	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Musculoskeletal and connective tissue disorders Arthritis	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Aspartate aminotransferase Increased	50.0% 10/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Cardiac disorders Atrial flutter	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Bloating	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Blood bilirubin increased	25.0% 5/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Eye disorders blurred vision	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Musculoskeletal and connective tissue disorders bone pain	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Injury, poisoning and procedural complications Burn	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations Catheter Related Infection	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
General disorders Chills	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Psychiatric disorders Confusion	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Constipation	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Respiratory, thoracic and mediastinal disorders cough	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Creatinine increased	30.0% 6/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders dehydration	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Injury, poisoning and procedural complications Dermatitis radiation	30.0% 6/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Diarrhea	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Dizziness	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Dry mouth	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders dry skin	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Dysgeusia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Dyspepsia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Dysphagia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
General disorders Edema limbs	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Ejection fraction decreased	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders encephalopathy	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
General disorders Fatigue	50.0% 10/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Blood and lymphatic system disorders Febrile Neutropenia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
General disorders fever	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Vascular disorders flushing	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Injury, poisoning and procedural complications Fracture	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Gastroesophageal reflux disease	20.0% 4/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Headache	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Renal and urinary disorders Hematuria	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders hemorrhoids	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Respiratory, thoracic and mediastinal disorders hiccups	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Vascular disorders Hot flashes	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypercalcemia	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hyperglycemia	55.0% 11/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders hyperkalemia	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders hypermagnesemia	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypernatremia	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Vascular disorders Hypertension	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypoalbuminemia	80.0% 16/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders hypocalcemia	60.0% 12/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypoglycemia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypokalemia	55.0% 11/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypomagnesemia	60.0% 12/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hyponatremia	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Metabolism and nutrition disorders Hypophosphatemia	80.0% 16/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Vascular disorders Hypotension	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Psychiatric disorders Insomnia	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations Lip Infection	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Lipase increased	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Lymphocyte count decreased	100.0% 20/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders mucositis oral	40.0% 8/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders nausea	65.0% 13/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Neutrophil Count Decreased	90.0% 18/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
General disorders non-cardiac chest pain	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
General disorders pain	30.0% 6/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	25.0% 5/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Pancreatitis	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Paresthesia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Peripheral Motor Neuropathy	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations Platelet count decreased	100.0% 20/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Injury, poisoning and procedural complications Postoperative hemorrhage	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations prostate infection	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders Pruritus	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders Rash Acneiform	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Skin and subcutaneous tissue disorders Rash maculo-papular	50.0% 10/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders Rectal Hemorrhage	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Cardiac disorders Sinus Tachycardia	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Respiratory, thoracic and mediastinal disorders Sore Throat	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment Related Secondary Malignancy	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Nervous system disorders Tremor	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations Urinary tract infection	10.0% 2/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Reproductive system and breast disorders Vaginal hemorrhage	5.0% 1/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Gastrointestinal disorders vomiting	50.0% 10/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations weight loss	25.0% 5/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Investigations White Blood Cell Decreased	90.0% 18/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Injury, poisoning and procedural complications wound dehiscence	15.0% 3/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.
Infections and infestations wound infection	30.0% 6/20 • Toxicity measure through follow up, every 4 months until patient death or withdrawal, a median of 34.5 months. Adverse events will be using the NCI Common Toxicity Criteria for Adverse Events v4.0. Assessment of study drug attribution will be made by an Investigator. Acute and long-term radiation toxicity will be assessed for the following CTCAE categories: 1) Injury, poisoning and procedural complications: Dermatitis radiation 2) Musculoskeletal and connective tissue disorders: Fibrosis 3) other appropriate Musculoskeletal and connective tissue disorders AEs appropriate to limb function.

Additional Information

Christopher Ryan, MD

OHSU Knight Cancer Institute

Phone: 503-494-8487

Email: ryanc@ohsu.edu

Results disclosure agreements

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