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

May 6, 2011 updated by: National University Hospital, Singapore
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital
        • Principal Investigator:
          • Jeremy Tey, FRANZCR
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy for gastric cancer
Single arm study
Radiation: Palliative Radiotherapy
Palliative Radiotherapy to a total dose of 36Gy in 12 fractions
Other Names:
  • palliation, radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the 12th fraction of radiotherapy and at one month post radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0
Time Frame: within the first 14 days from start of radiotherapy
Toxicity
within the first 14 days from start of radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Tan Tock Seng Hospital

Investigators

  • Principal Investigator: Jeremy Tey, FRANZCR, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

July 1, 2011

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 24, 2011

First Posted (Estimate)

April 26, 2011

Study Record Updates

Last Update Posted (Estimate)

May 9, 2011

Last Update Submitted That Met QC Criteria

May 6, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B/09/134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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