Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
21 Years
N/A
Both
Gastric Cancer
Trial Information
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
The hypothesis of this study is that a radiotherapy dose of 36Gy in 12 fractions, which
equates to a BED of 48.6Gy, increases the response rates of symptom relief compared to
historical controls. (Tey et al.) With this dose fractionation is used for bleeding, there
is an increase in response rates from 55%(historical) to 75%for pain, there is an increase
in response rates from 25% (historical) to 45% for obstruction, there is an increase in
response rates from 25% (historical) to 45%
Inclusion Criteria:
- Biopsy proven adenocarcinoma of the stomach
- Treated with palliative intent
- At least one index symptom such as bleeding, obstruction or pain
- No prior abdominal radiotherapy
- Not on chemotherapy
Exclusion Criteria:
- Patients treated with radical intent
- Previous abdominal radiotherapy
- Patients on chemotherapy
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response of bleeding to radiotherapy
Outcome Description:
Percentage of patients who do not require blood transfusion after radiotherapy
Outcome Time Frame:
At the 12th fraction of radiotherapy and at one month post radiotherapy
Safety Issue:
No
Principal Investigator
Jeremy Tey, FRANZCR
Investigator Role:
Principal Investigator
Investigator Affiliation:
National University Hospital, Singapore
Authority:
Singapore: Domain Specific Review Boards
Study ID:
B/09/134
NCT ID:
NCT01341756
Start Date:
July 2009
Completion Date:
July 2012
Related Keywords:
- Gastric Cancer
- Gastric Cancer
- Radiotherapy
- palliation
- bleeding
- pain
- obstruction
- Stomach Neoplasms
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