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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Palliative Radiotherapy
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy for gastric cancer

Arm Description

Single arm study

Outcomes

Primary Outcome Measures

Response of bleeding to radiotherapy
Percentage of patients who do not require blood transfusion after radiotherapy

Secondary Outcome Measures

Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0
Toxicity

Full Information

First Posted
April 18, 2011
Last Updated
May 6, 2011
Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01341756
Brief Title
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Official Title
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy for gastric cancer
Arm Type
Experimental
Arm Description
Single arm study
Intervention Type
Radiation
Intervention Name(s)
Palliative Radiotherapy
Other Intervention Name(s)
palliation, radiotherapy
Intervention Description
Palliative Radiotherapy to a total dose of 36Gy in 12 fractions
Primary Outcome Measure Information:
Title
Response of bleeding to radiotherapy
Description
Percentage of patients who do not require blood transfusion after radiotherapy
Time Frame
At the 12th fraction of radiotherapy and at one month post radiotherapy
Secondary Outcome Measure Information:
Title
Number of patients who develop anorexia, nausea, vomiting as per common toxicity criteria v3.0
Description
Toxicity
Time Frame
within the first 14 days from start of radiotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremy Tey, FRANZCR
Phone
+65 67724869
Email
jeremy_tey@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Tey, FRANZCR
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Tey, FRANZCR
Phone
+65 67724869
Email
jeremy_Tey@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Jeremy Tey, FRANZCR

12. IPD Sharing Statement

Citations:
PubMed Identifier
30790469
Citation
Tey J, Zheng H, Soon YY, Leong CN, Koh WY, Lim K, So JBY, Shabbir A, Tham IWK, Lu J. Palliative radiotherapy in symptomatic locally advanced gastric cancer: A phase II trial. Cancer Med. 2019 Apr;8(4):1447-1458. doi: 10.1002/cam4.2021. Epub 2019 Feb 20.
Results Reference
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Learn more about this trial

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

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