Trial Outcomes & Findings for Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma (NCT NCT00976898)

Last Updated: 2025-09-15

Results Overview

The percentage of participants with local control after two years as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. The duration of control was measured from the start of treatment. Local control is the absence of local failure. Local Failure is defined as evidence of tumor growth/regrowth in any direction beyond that present of the pre-treatment imaging studies in the treated lesion(s).

Recruitment status

COMPLETED

Study phase

Target enrollment

83 participants

Primary outcome timeframe

2 years

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Proton Beam Irradiation This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Overall Study STARTED	83
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Proton Beam Irradiation This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Overall Study Protocol Violation	1
Overall Study Adverse Event	1
Overall Study Physician Decision	1
Overall Study Liver Transplant	1
Overall Study Progressive Disease	1

Baseline Characteristics

Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer and Cholangiocarcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Proton Beam Irradiation n=83 Participants This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Age, Continuous	67.6 years n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race/Ethnicity, Customized White	76 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic (white or black)	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	1 Participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants
Underlying Liver Disease Hepatitis C Virus (HCV) (± Others)	28 Participants n=5 Participants
Underlying Liver Disease No HCV but Hepatitis B Virus (HBV) (± Others)	6 Participants n=5 Participants
Underlying Liver Disease No HCV/HBV but Ethyl Hepatocellularalcohol (EtOH)	8 Participants n=5 Participants
Underlying Liver Disease No HCV/HBV/EtOH but nonalcoholic steatohepatitis	3 Participants n=5 Participants
Underlying Liver Disease Other	2 Participants n=5 Participants
Underlying Liver Disease None	36 Participants n=5 Participants
ECOG Performance Status 0	28 Participants n=5 Participants
ECOG Performance Status 1	52 Participants n=5 Participants
ECOG Performance Status 2	3 Participants n=5 Participants
Child-Turcotte-Pugh Class A	66 Participants n=5 Participants
Child-Turcotte-Pugh Class B	15 Participants n=5 Participants
Child-Turcotte-Pugh Class C	0 Participants n=5 Participants
Child-Turcotte-Pugh Class No Cirrhosis	4 Participants n=5 Participants
Disease Status Locally Recurrent	5 Participants n=5 Participants
Disease Status Newly Diagnosed	78 Participants n=5 Participants
Number of Nodular Tumors 1	66 Participants n=5 Participants
Number of Nodular Tumors 2	15 Participants n=5 Participants
Number of Nodular Tumors 3	4 Participants n=5 Participants
Previous Therapy Any surgical resection	4 Participants n=5 Participants
Previous Therapy Any transarterial chemoembolization	5 Participants n=5 Participants
Previous Therapy Any radiofrequency ablation	2 Participants n=5 Participants
Previous Therapy Any chemotherapy	27 Participants n=5 Participants
Previous Therapy Any other	15 Participants n=5 Participants
Previous Therapy None	45 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Proton Beam Irradiation n=83 Participants This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
2 Year Local Control Rate	94.4 percentage of participants Interval 87.2 to 98.2

PRIMARY outcome

Timeframe: 5 years

The median survival time in months as measured from the start of treatment until death due to any cause or until the participants is censored. Participants are censored at the date of their last follow-up.

Outcome measures

Outcome measures
Measure	Proton Beam Irradiation n=83 Participants This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Median Overall Survival	49.9 Months Interval 17.8 to Upper bound not reached because of living subjects

SECONDARY outcome

Timeframe: 2 years

Summary of the proton radiation related grade 3 or greater adverse events that participants experienced. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE v3).

Outcome measures

Outcome measures
Measure	Proton Beam Irradiation n=83 Participants This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Number of Participants With Treatment Related Adverse Events ≥ Grade 3 Liver Failure	1 Participants
Number of Participants With Treatment Related Adverse Events ≥ Grade 3 Platelets	1 Participants
Number of Participants With Treatment Related Adverse Events ≥ Grade 3 Ascites (nonmalignant)	1 Participants
Number of Participants With Treatment Related Adverse Events ≥ Grade 3 Ulcer, GI - stomach	1 Participants
Number of Participants With Treatment Related Adverse Events ≥ Grade 3 Bilirubin (hyperbilirubinemia)	1 Participants

SECONDARY outcome

Timeframe: 2 years

A summary of the patterns of treatment failure, shown as the number of participants that fall into each category at the end of study follow-up

Outcome measures

Outcome measures
Measure	Proton Beam Irradiation n=83 Participants This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Patterns of Failure Dead of other causes, no progression	9 Participants
Patterns of Failure Alive, no progression	26 Participants
Patterns of Failure Distant metastases	38 Participants
Patterns of Failure Local failure and distant metastases	3 Participants
Patterns of Failure Isolated local failure	5 Participants
Patterns of Failure Dead of disease, no progression	2 Participants

Adverse Events

Proton Beam Irradiation

Serious events: 8 serious events

Other events: 81 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Proton Beam Irradiation n=83 participants at risk This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Gastrointestinal disorders Ascites (non-malignant)	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Bilirubin (hyperbilirubinemia)	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Encephalopathy	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Fatigue (asthenia, lethargy, malaise)	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Injury, poisoning and procedural complications Fracture	2.4% 2/83 • Number of events 2 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Infections and infestations Infection with unknown ANC - Abdomen NOS	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Platelets	1.2% 1/83 • Number of events 2 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	1.2% 1/83 • Number of events 1 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.

Other adverse events

Other adverse events
Measure	Proton Beam Irradiation n=83 participants at risk This is a single arm study. All study participants will receive proton radiation therapy. Proton Beam Irradiation: Given once a day, 5 days a week, for 3 weeks
Investigations Alkaline phosphatase	15.7% 13/83 • Number of events 40 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations ALT, SGPT (serum glutamic pyruvic transaminase)	13.3% 11/83 • Number of events 41 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Metabolism and nutrition disorders Anorexia	45.8% 38/83 • Number of events 92 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Arthritis (non-septic)	6.0% 5/83 • Number of events 10 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Ascites (non-malignant)	24.1% 20/83 • Number of events 43 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations AST, SGOT(serum glutamic oxaloacetic transaminase)	25.3% 21/83 • Number of events 75 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Bilirubin (hyperbilirubinemia)	21.7% 18/83 • Number of events 79 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Blood and lymphatic system disorders Blood/Bone Marrow - Other	19.3% 16/83 • Number of events 47 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Injury, poisoning and procedural complications Bruising (in absence of Grade 3 or 4 thrombocytopenia)	9.6% 8/83 • Number of events 23 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Cardiac disorders Cardiac General - Other	6.0% 5/83 • Number of events 14 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Constipation	16.9% 14/83 • Number of events 33 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Respiratory, thoracic and mediastinal disorders Cough	15.7% 13/83 • Number of events 23 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	15.7% 13/83 • Number of events 41 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Diarrhea	21.7% 18/83 • Number of events 31 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Distension/bloating, abdominal	19.3% 16/83 • Number of events 29 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Dizziness	13.3% 11/83 • Number of events 25 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	27.7% 23/83 • Number of events 38 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Edema: limb	26.5% 22/83 • Number of events 60 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Encephalopathy	6.0% 5/83 • Number of events 6 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Extremity-lower (gait/walking)	6.0% 5/83 • Number of events 12 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Fatigue (asthenia, lethargy, malaise)	80.7% 67/83 • Number of events 316 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	10.8% 9/83 • Number of events 25 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Injury, poisoning and procedural complications Fracture	8.4% 7/83 • Number of events 20 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Gastrointestinal - Other	15.7% 13/83 • Number of events 29 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	10.8% 9/83 • Number of events 34 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Heartburn/dyspepsia	13.3% 11/83 • Number of events 25 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Blood and lymphatic system disorders Hemoglobin	10.8% 9/83 • Number of events 25 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Hyperpigmentation	15.7% 13/83 • Number of events 32 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Vascular disorders Hypertension	6.0% 5/83 • Number of events 10 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Vascular disorders Hypotension	10.8% 9/83 • Number of events 16 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Psychiatric disorders Insomnia	12.0% 10/83 • Number of events 25 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Leukocytes (total WBC)	8.4% 7/83 • Number of events 21 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Memory impairment	6.0% 5/83 • Number of events 9 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Metabolic/Laboratory - Other	6.0% 5/83 • Number of events 10 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Psychiatric disorders Mood alteration - Anxiety	12.0% 10/83 • Number of events 22 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Psychiatric disorders Depression	9.6% 8/83 • Number of events 24 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized	9.6% 8/83 • Number of events 13 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Musculoskeletal/Soft Tissue - Other	8.4% 7/83 • Number of events 15 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Nausea	48.2% 40/83 • Number of events 104 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Neuropathy: sensory	6.0% 5/83 • Number of events 18 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Neutrophils/granulocytes (ANC/AGC)	8.4% 7/83 • Number of events 12 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Pain - Abdomen NOS	43.4% 36/83 • Number of events 136 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Pain - Back	14.5% 12/83 • Number of events 21 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Pain - Chest wall	10.8% 9/83 • Number of events 17 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Pain - Chest/thorax NOS	7.2% 6/83 • Number of events 8 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Pain - Extremity-limb	10.8% 9/83 • Number of events 19 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Pain - Head/headache	7.2% 6/83 • Number of events 11 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Musculoskeletal and connective tissue disorders Pain - Joint	9.6% 8/83 • Number of events 16 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Pain - Other	16.9% 14/83 • Number of events 33 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Platelets	28.9% 24/83 • Number of events 90 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	8.4% 7/83 • Number of events 13 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Pruritus/itching	7.2% 6/83 • Number of events 13 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory - Other	8.4% 7/83 • Number of events 17 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Rash/desquamation	6.0% 5/83 • Number of events 8 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Chemoradiation	6.0% 5/83 • Number of events 5 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Rash: dermatitis associated with radiation - Radiation	61.4% 51/83 • Number of events 194 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
General disorders Rigors/chills	10.8% 9/83 • Number of events 13 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	9.6% 8/83 • Number of events 16 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Nervous system disorders Somnolence/depressed level of consciousness	6.0% 5/83 • Number of events 5 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Skin and subcutaneous tissue disorders Ulceration	6.0% 5/83 • Number of events 8 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Renal and urinary disorders Urinary frequency/urgency	9.6% 8/83 • Number of events 18 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Renal and urinary disorders Urine color change	6.0% 5/83 • Number of events 5 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Gastrointestinal disorders Vomiting	21.7% 18/83 • Number of events 22 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.
Investigations Weight loss	14.5% 12/83 • Number of events 40 • Adverse event information was collected from the start of treatment until 30 days after the last study visit. Radiation was delivered in 15 fractions Monday through Friday over a period of three weeks. Follow-up visits occurred at 1, 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 months post treatment. Median follow-up was 19.5 months. Adverse events were assessed with the use of regularly scheduled visits which involved physical exams, CT and/or MRI scans, laboratory tests, and patient self reporting. If an adverse event did not match any of the existing CTCAE 3 terms, it was noted as being 'other'. Adverse events noted as being 'other' were only grouped together by organ system due to incomplete data about what specific adverse event was being recorded as 'other'.

Additional Information

Theodore Sunki Hong, MD

Massachusetts General Hospital

Phone: 617-724-1159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place