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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tan Tock Seng Hospital
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01341756
First received: April 18, 2011
Last updated: May 6, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Radiation: Palliative Radiotherapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Palliative Radiotherapy for Symptomatic Locally Advanced Gastric Cancer: A Phase II Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Response of bleeding to radiotherapy [ Time Frame: At the 12th fraction of radiotherapy and at one month post radiotherapy ] [ Designated as safety issue: No ]
    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 [ Time Frame: within the first 14 days from start of radiotherapy ] [ Designated as safety issue: Yes ]
    Toxicity


Estimated Enrollment: 63
Study Start Date: July 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiotherapy for gastric cancer
Single arm study
 Radiation: Palliative Radiotherapy
Palliative Radiotherapy to a total dose of 36Gy in 12 fractions
Other Name: palliation, radiotherapy

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%

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341756

Contacts
Contact: Jeremy Tey, FRANZCR +65 67724869 jeremy_tey@nuhs.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Jeremy Tey, FRANZCR     +65 67724869     jeremy_Tey@nuhs.edu.sg    
Principal Investigator: Jeremy Tey, FRANZCR            
Sponsors and Collaborators
National University Hospital, Singapore
Tan Tock Seng Hospital
Investigators
Principal Investigator: Jeremy Tey, FRANZCR National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Jeremy Tey, National University Hospital
ClinicalTrials.gov Identifier: NCT01341756     History of Changes
Other Study ID Numbers: B/09/134
Study First Received: April 18, 2011
Last Updated: May 6, 2011
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Gastric Cancer
Radiotherapy
palliation
 bleeding
pain
obstruction

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on June 13, 2013