- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01341756
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 Contact
- Name: Jeremy Tey, FRANZCR
- Phone Number: +65 67724869
- Email: jeremy_Tey@nuhs.edu.sg
Study Locations
-
-
-
Singapore, Singapore
- Recruiting
- National University Hospital
-
Principal Investigator:
- Jeremy Tey, FRANZCR
-
Contact:
- Jeremy Tey, FRANZCR
- Phone Number: +65 67724869
- Email: jeremy_Tey@nuhs.edu.sg
-
-
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
|
Palliative Radiotherapy to a total dose of 36Gy in 12 fractions
Other Names:
|
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.
Collaborators
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.
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
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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