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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01341756
• Other study ID #: B/09/134
• Status: Recruiting
• Phase: Phase 2
• First received: April 18, 2011
• Last updated: May 6, 2011
• Start date: July 2009
• Est. completion date: July 2012

Study information

• Verified date: April 2011
• Source: National University Hospital, Singapore
• Contact: Jeremy Tey, FRANZCR
• Phone: +65 67724869
• Email: jeremy_tey[@]nuhs.edu.sg
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Radiation:
• Palliative Radiotherapy
Palliative Radiotherapy to a total dose of 36Gy in 12 fractions

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response of bleeding to radiotherapy	Percentage of patients who do not require blood transfusion after radiotherapy	At the 12th fraction of radiotherapy and at one month post radiotherapy	No
Secondary	Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0	Toxicity	within the first 14 days from start of radiotherapy	Yes