Trial Outcomes & Findings for Individualized Stereotactic Body Radiotherapy of Liver Metastases (NCT NCT01239381)

Last Updated: 2025-09-30

Results Overview

The percentage of participants with local control at primary tumor site at one year. Local is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). Local control is defined as achieving either Complete response (CR), Partial Response (PR), or Stable Disease (SD). * (CR): Disappearance of entire lesion, with no additional evidence of disease. * (PR): At least a 30% decrease in the (sum of) the longest diameter (LD) of the primary lesion, taken as reference the baseline sum LD. * (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Recruitment status

COMPLETED

Study phase

Target enrollment

92 participants

Primary outcome timeframe

1 year

Results posted on

2025-09-30

Participant Flow

Participant milestones

Participant milestones
Measure	SBRT-Proton Stereotactic Body Radiation Therapy (SBRT) by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Overall Study STARTED	92
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SBRT-Proton Stereotactic Body Radiation Therapy (SBRT) by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

88 participants with complete tumor size data

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT-Proton n=90 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Age, Continuous	68 years n=90 Participants
Sex: Female, Male Female	33 Participants n=90 Participants
Sex: Female, Male Male	57 Participants n=90 Participants
Region of Enrollment United States	90 Participants n=90 Participants
Primary Cancer Site Colorectal	35 Participants n=90 Participants
Primary Cancer Site Pancreatic	16 Participants n=90 Participants
Primary Cancer Site Esophagogastric	12 Participants n=90 Participants
Primary Cancer Site Hepatocellular	8 Participants n=90 Participants
Primary Cancer Site Lung	5 Participants n=90 Participants
Primary Cancer Site Gallbladder	3 Participants n=90 Participants
Primary Cancer Site Breast	3 Participants n=90 Participants
Primary Cancer Site Small Bowel or Duodenal	3 Participants n=90 Participants
Primary Cancer Site Anal	2 Participants n=90 Participants
Primary Cancer Site Head and Neck	2 Participants n=90 Participants
Primary Cancer Site Prostate	1 Participants n=90 Participants
Number of Tumors 1 Tumor	54 Participants n=90 Participants
Number of Tumors 2 Tumors	21 Participants n=90 Participants
Number of Tumors 3 Tumors	10 Participants n=90 Participants
Number of Tumors 4 Tumors	5 Participants n=90 Participants
Median Tumor Size	2.55 Centimeters (cm) n=90 Participants
Categorical Tumor size ≤ 5 cm	50 Participants n=88 Participants • 88 participants with complete tumor size data
Categorical Tumor size > 5 cm	31 Participants n=88 Participants • 88 participants with complete tumor size data
Categorical Tumor size > 10 cm	7 Participants n=88 Participants • 88 participants with complete tumor size data

PRIMARY outcome

Timeframe: 1 year

Population: The 90 participants that started study treatment

Outcome measures

Outcome measures
Measure	SBRT-Proton n=90 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Local Control Rate	77 percentage of participants

SECONDARY outcome

Timeframe: 1 year

Population: the 39 participants still alive at the time of analysis

The median follow-up time among the 39 participants still alive at the time of analysis, measured from the start of treatment until the time of analysis.

Outcome measures

Outcome measures
Measure	SBRT-Proton n=39 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Median Follow-up Time	11 Months Interval 0.3 to 41.0

SECONDARY outcome

Timeframe: 2 years

The median overall survival (in months) of participants as measured from the start of treatment.

Outcome measures

Outcome measures
Measure	SBRT-Proton n=90 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Median Overall Survival	18 Months Interval 14.0 to 21.0

SECONDARY outcome

Timeframe: 1 years

The median amount of time participants survived without cancer progression following the start of study treatment. Progression was assessed using RECIST v1.0. Progressive Disease (PD) is defined as at least a 20% increase in the Longest Diameter (LD) of the lesion, taken as the reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Outcome measures

Outcome measures
Measure	SBRT-Proton n=90 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Median Progression Free Survival	4 Months Interval 3.0 to 8.0

SECONDARY outcome

Timeframe: 2 years

The percentage of participants with local control 2 years after the start of study treatment.

Outcome measures

Outcome measures
Measure	SBRT-Proton n=90 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
2-year Local Control Rate	65.8 percentage of participants Interval 55.8 to 75.6

SECONDARY outcome

Timeframe: 1 year

Population: Participants with colorectal cancer

The percentage of participants with local control at one year among the participants with colorectal cancer as the primary cancer.

Outcome measures

Outcome measures
Measure	SBRT-Proton n=35 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
1 Year Local Control Rate Among Participants With Colorectal Cancer	60 percentage of participants

SECONDARY outcome

Timeframe: 2 years

Population: The 35 participants with colorectal cancer as the primary cancer.

The median amount of time participants survived from the start of treatment, among the participants with colorectal cancer.

Outcome measures

Outcome measures
Measure	SBRT-Proton n=35 Participants SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Median Survival Among Participants With Colorectal Cancer	18 Months Interval 13.0 to 32.0

Adverse Events

SBRT-Proton

Serious events: 0 serious events

Other events: 86 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SBRT-Proton n=90 participants at risk SBRT by proton radiation Stereotactic body radiotherapy-proton: Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
Ear and labyrinth disorders Ear pain	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Blood and lymphatic system disorders Anemia	11.1% 10/90 • Number of events 22 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Cardiac disorders Atrial fibrillation	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Cardiac disorders Chest pain - cardiac	3.3% 3/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Cardiac disorders Palpitations	1.1% 1/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Cardiac disorders Ventricular arrhythmia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Chills	2.2% 2/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Edema limbs	7.8% 7/90 • Number of events 16 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Fatigue	77.8% 70/90 • Number of events 205 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Fever	4.4% 4/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Gait disturbance	2.2% 2/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Localized edema	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Malaise	3.3% 3/90 • Number of events 7 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Non-cardiac chest pain	3.3% 3/90 • Number of events 7 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders Pain	16.7% 15/90 • Number of events 28 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
General disorders General disorders and administration site conditions - Other,	2.2% 2/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Alopecia	3.3% 3/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Dry skin	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Pruritus	2.2% 2/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	5.6% 5/90 • Number of events 18 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Skin ulceration	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Telangiectasia	1.1% 1/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.6% 5/90 • Number of events 8 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Abdominal distension	3.3% 3/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Abdominal pain	38.9% 35/90 • Number of events 90 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Ascites	2.2% 2/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Bloating	7.8% 7/90 • Number of events 12 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Constipation	11.1% 10/90 • Number of events 16 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Diarrhea	15.6% 14/90 • Number of events 30 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Dyspepsia	5.6% 5/90 • Number of events 8 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Dysphagia	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Fecal incontinence	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Flatulence	2.2% 2/90 • Number of events 5 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Gastroesophageal reflux disease	4.4% 4/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Gastroparesis	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Hemorrhoidal hemorrhage	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Nausea	24.4% 22/90 • Number of events 34 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Pancreatitis	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Rectal pain	4.4% 4/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Stomach pain	1.1% 1/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Vomiting	7.8% 7/90 • Number of events 8 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	5.6% 5/90 • Number of events 7 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Hepatobiliary disorders Portal vein thrombosis	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Infections and infestations Lung infection	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Infections and infestations Papulopustular rash	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Infections and infestations Rash pustular	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Infections and infestations Upper respiratory infection	5.6% 5/90 • Number of events 11 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Infections and infestations Urinary tract infection	4.4% 4/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Infections and infestations Infections and infestations - Other, specify	3.3% 3/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Injury, poisoning and procedural complications Bruising	5.6% 5/90 • Number of events 14 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Injury, poisoning and procedural complications Dermatitis radiation	44.4% 40/90 • Number of events 101 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Injury, poisoning and procedural complications Fall	2.2% 2/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Injury, poisoning and procedural complications Fracture	1.1% 1/90 • Number of events 5 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Alanine aminotransferase increased	11.1% 10/90 • Number of events 19 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Alkaline phosphatase increased	13.3% 12/90 • Number of events 33 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Aspartate aminotransferase increased	11.1% 10/90 • Number of events 20 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Blood bilirubin increased	8.9% 8/90 • Number of events 25 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Blood prolactin abnormal	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Lymphocyte count decreased	2.2% 2/90 • Number of events 5 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Platelet count decreased	5.6% 5/90 • Number of events 16 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Serum amylase increased	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Weight gain	5.6% 5/90 • Number of events 11 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Weight loss	8.9% 8/90 • Number of events 14 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations White blood cell decreased	2.2% 2/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Investigations Investigations - Other, specify	5.6% 5/90 • Number of events 10 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Alkalosis	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Anorexia	27.8% 25/90 • Number of events 49 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Dehydration	2.2% 2/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Hypercalcemia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Hyperglycemia	5.6% 5/90 • Number of events 7 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Hyperkalemia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Metabolism and nutrition disorders Hyponatremia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Arthritis	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Back pain	12.2% 11/90 • Number of events 24 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Bone pain	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Buttock pain	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Chest wall pain	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Flank pain	4.4% 4/90 • Number of events 7 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Muscle weakness left-sided	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Myalgia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Neck pain	4.4% 4/90 • Number of events 8 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Osteoporosis	1.1% 1/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	13.3% 12/90 • Number of events 26 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder -	4.4% 4/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Akathisia	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Dizziness	10.0% 9/90 • Number of events 11 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Dysgeusia	1.1% 1/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Headache	4.4% 4/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Memory impairment	4.4% 4/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Paresthesia	2.2% 2/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Peripheral motor neuropathy	2.2% 2/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Peripheral sensory neuropathy	6.7% 6/90 • Number of events 10 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Somnolence	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Tremor	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Nervous system disorders Nervous system disorders - Other, specify	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) polyps) - Other, specify	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Eye disorders Eye pain	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Psychiatric disorders Agitation	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Psychiatric disorders Anxiety	5.6% 5/90 • Number of events 8 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Psychiatric disorders Confusion	3.3% 3/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Psychiatric disorders Depression	6.7% 6/90 • Number of events 13 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Psychiatric disorders Insomnia	6.7% 6/90 • Number of events 7 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Aspiration	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Cough	4.4% 4/90 • Number of events 5 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	11.1% 10/90 • Number of events 14 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Hoarseness	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Postnasal drip	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	3.3% 3/90 • Number of events 5 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Chronic kidney disease	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Hematuria	2.2% 2/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Proteinuria	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Urinary frequency	2.2% 2/90 • Number of events 4 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Urinary incontinence	1.1% 1/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Urinary retention	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Urine discoloration	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Reproductive system and breast disorders Pelvic pain	3.3% 3/90 • Number of events 8 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Reproductive system and breast disorders Prostatic obstruction	1.1% 1/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Vascular disorders Flushing	1.1% 1/90 • Number of events 1 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Vascular disorders Hematoma	2.2% 2/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Vascular disorders Hot flashes	2.2% 2/90 • Number of events 3 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Vascular disorders Hypertension	4.4% 4/90 • Number of events 6 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.
Vascular disorders Superficial thrombophlebitis	1.1% 1/90 • Number of events 2 • From the start of treatment until 30 days after the completion of treatment Participants are assessed for adverse events twice during treatment, after 4 weeks of followup, and then every three months until 24 months post treatment.

Additional Information

Theodore S Hong, MD, physician radiation oncology

Massachusetts General Hospital

Phone: 617-726-6050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place