Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Conditions
Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Palliative Radiotherapy
Type: Radiation
Overall Status
Recruiting
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%
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
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
Location
National University Hospital
Singapore, Singapore
Status: Recruiting
Contact: Jeremy Tey, FRANZCR - +65 67724869 - jeremy_Tey@nuhs.edu.sg
Start Date
July 2009
Completion Date
July 2012
Sponsors
National University Hospital, Singapore
Source
National University Hospital, Singapore
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page