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
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric Cancer, Radiotherapy, palliation, bleeding, pain, obstruction
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
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
NCT ID
NCT01341756
First Posted
April 18, 2011
Last Updated
May 6, 2011
Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital
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
derived
Learn more about this trial
Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial
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