Trial Outcomes & Findings for Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer (NCT NCT00607828)
NCT ID: NCT00607828
Last Updated: 2024-11-04
Results Overview
Toxicity as assessed by NCI CTCAE v3.0 (Adverse Events). Due to delayed toxicities attributable to radiotherapy, all toxicities observed within 1 month after SRT will be scored. Dose limiting toxicity (DLT) is defined as any of following toxicities, that is possibly, probably or definitely related to Stereotactic Radiation Therapy (SRT) occurring within 1 month from the start of treatment: 1. grade 4 or 5 hepatic 2. grade 4 or 5 gastrointestinal 3. grade 4 or 5 thrombocytopenia 4. grade 4 hepatic liver enzyme elevations persisting for ≥ 5 days 5. any adverse event requiring interruption of therapy by ≥ 2 weeks (14 calendar days).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Up to 1 month after Stereotactic Radiation Therapy (SRT) treatment
Results posted on
2024-11-04
Participant Flow
Participant milestones
| Measure |
10 Gy x 5
Dose Level 10 Gy x 5
|
12 Gy x 5
Dose Level 12 Gy x 5
|
14 Gy x 5
Dose Level 14 Gy x 5
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Radiation Therapy in Treating Patients With Advanced Liver Cancer
Baseline characteristics by cohort
| Measure |
10 Gy x 5
n=3 Participants
Dose Level 10 Gy x 5
|
12 Gy x 5
n=3 Participants
Dose level 12 Gy x 5
|
14 Gy x 5
n=1 Participants
Dose level 14 Gy x 5
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
00 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
1 participants
n=27 Participants
|
7 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Up to 1 month after Stereotactic Radiation Therapy (SRT) treatmentToxicity as assessed by NCI CTCAE v3.0 (Adverse Events). Due to delayed toxicities attributable to radiotherapy, all toxicities observed within 1 month after SRT will be scored. Dose limiting toxicity (DLT) is defined as any of following toxicities, that is possibly, probably or definitely related to Stereotactic Radiation Therapy (SRT) occurring within 1 month from the start of treatment: 1. grade 4 or 5 hepatic 2. grade 4 or 5 gastrointestinal 3. grade 4 or 5 thrombocytopenia 4. grade 4 hepatic liver enzyme elevations persisting for ≥ 5 days 5. any adverse event requiring interruption of therapy by ≥ 2 weeks (14 calendar days).
Outcome measures
| Measure |
10 Gy x 5
n=3 Participants
Dose Level 10 Gy x 5
|
12 Gy x 5
n=3 Participants
Dose Level 12 Gy x 5
|
14 Gy x 5
n=1 Participants
Dose Level 12 Gy x 5
|
|---|---|---|---|
|
The Safety of Hypofractionated Stereotactic Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
Experienced at least 1 Toxicity
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Safety of Hypofractionated Stereotactic Radiotherapy in Patients With Advanced Hepatocellular Carcinoma
Experienced No Toxicities
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured from first day of SRT to 1-month post SRT.Response rate from tumor measurement at 1-month post-SRT
Outcome measures
| Measure |
10 Gy x 5
n=3 Participants
Dose Level 10 Gy x 5
|
12 Gy x 5
n=3 Participants
Dose Level 12 Gy x 5
|
14 Gy x 5
n=1 Participants
Dose Level 12 Gy x 5
|
|---|---|---|---|
|
Response at 1-month Post SRT
PR
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Response at 1-month Post SRT
SD
|
0 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
10 Gy x 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
12 Gy x 5
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
14 Gy x 5
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
10 Gy x 5
n=3 participants at risk
Dose Level 10 Gy x 5
|
12 Gy x 5
n=3 participants at risk
Dose Level 12 Gy x 5
|
14 Gy x 5
n=1 participants at risk
Dose Level 14 Gy x 5
|
|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
66.7%
2/3 • Number of events 2 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 2 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
33.3%
1/3 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Metabolism and nutrition disorders
Aspartate Aminotransferase (AST)
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Metabolism and nutrition disorders
Alanine Transaminase (ALT)
|
33.3%
1/3 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Metabolism and nutrition disorders
Bilirubin
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
33.3%
1/3 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
66.7%
2/3 • Number of events 2 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
General disorders
Fever
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
0.00%
0/3 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
100.0%
1/1 • Number of events 1 • Toxicity data was collected up to 3 months post-RT.
toxicity according Common Terminology Criteria for Adverse Events v.3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place