Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Gastric Cancer
- Sponsor
- National University Hospital, Singapore
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Response of bleeding to radiotherapy
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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%
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Response of bleeding to radiotherapy
Time Frame: At the 12th fraction of radiotherapy and at one month post radiotherapy
Percentage of patients who do not require blood transfusion after radiotherapy
Secondary Outcomes
- Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0(within the first 14 days from start of radiotherapy)