Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Phase 2

• Conditions: Gastric Cancer
• Interventions: Radiation: Palliative Radiotherapy

• Registration Number: NCT01341756
• Lead Sponsor: National University Hospital, Singapore

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%

Study Timeline

• Study Start: 2009-07
• Status Verified: 2011-04
• Study First Submitted: 2011-04-18
• Study First Submitted QC: 2011-04-24
• Study First Posted: 2011-04-26
• Last Update Submitted: 2011-05-06
• Last Update Posted: 2011-05-09
• Primary Completion: 2011-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiotherapy for gastric cancer	Palliative Radiotherapy	Single arm study

Primary Outcome Measures

Name	Time	Method
Response of bleeding to radiotherapy	At the 12th fraction of radiotherapy and at one month post radiotherapy	Percentage of patients who do not require blood transfusion after radiotherapy

Secondary Outcome Measures

Name	Time	Method
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0	within the first 14 days from start of radiotherapy	Toxicity

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore