Back to resultsRadiation Therapy as Palliative Treatment of GIST (GIST-RT)
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 1
Locations
Finland
Study Type
Interventional
Intervention
Radiation therapy (external beam photons)
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring Gastrointestinal stromal tumor, GIST, Sarcoma, Radiation therapy, Radiotherapy
Eligibility Criteria
Inclusion Criteria:
- Histologically verified GIST.
- Metastatic or locally advanced, inoperable disease.
- Adequate systemic treatment has been administered.
- One or more growing GIST metastasis present during of after TKI therapy.
- The target lesion(s) is measurable.
- A written informed consent
Exclusion Criteria:
- WHO performance status is 4.
- Estimated life-expectancy less than 3 months.
- Radiation planning target volume greater than 3 dm3.
- Unmeasurable target lesion. Bone and brain metastases are not accepted target lesions.
- Radiation therapy cannot be delivered (e.g. active infection or restlessness.)
- Pregnancy.
- Systemic GIST treatment with unknown efficacy.
- Copies of CT images cannot be sent for central review.
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Radiotherapy
Arm Description
GIST patients who have progressing metastases will be treated with radiotherapy.
Outcomes
Primary Outcome Measures
Target tumor response rate
Secondary Outcome Measures
Time to progression of irradiated lesions
Time to progression of GIST
Control of GIST-related symptoms
Adverse effects of radiation therapy
Full Information
NCT ID
NCT00515931
First Posted
August 13, 2007
Last Updated
October 6, 2014
Sponsor
Heikki Joensuu
Collaborators
Lund University, University of Lausanne Hospitals
1. Study Identification
Unique Protocol Identification Number
NCT00515931
Brief Title
Radiation Therapy as Palliative Treatment of GIST
Acronym
GIST-RT
Official Title
Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heikki Joensuu
Collaborators
Lund University, University of Lausanne Hospitals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gastrointestinal stromal tumors (GISTs) are generally considered resistant to radiation, but no prospective trials addressing efficacy and tolerability of radiation therapy have been carried out. Limited clinical experience suggests that selected GIST patients may benefit from palliative radiation therapy. The purpose of this prospective, non-randomized, multicenter study is to evaluate efficacy and safety of palliative radiation therapy in GIST patients who have progressive GIST during or after tyrosine kinase inhibitor therapy.
Detailed Description
Radiation therapy planning must be based on computerized tomography (CT). External beam radiation must be used. Both 3D and IMRT plans are acceptable. The cumulative radiation dose may range from 30 to 40 Gy as administered in 1.8 to 2.0 Gy fractions, 5 fractions per week. The dose is specified as defined by the ICRU (International Commission on Radiation Units and Measurements) report 50. Response is evaluated using CT 6 and 12 weeks after irradiation. Adverse effects are evaluated using the Common Terminology Criteria for Adverse Effects (CTCAE)version 3.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
Gastrointestinal stromal tumor, GIST, Sarcoma, Radiation therapy, Radiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
GIST patients who have progressing metastases will be treated with radiotherapy.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy (external beam photons)
Other Intervention Name(s)
Radiotherapy, fractionated radiation therapy
Intervention Description
A cumulative radiation dose of 30 to 40 Gy is administered in 1.8 to 2.0 Gy fractions, 5 fractions per week, to the target lesion(s).
Primary Outcome Measure Information:
Title
Target tumor response rate
Time Frame
6 to 12 weeks
Secondary Outcome Measure Information:
Title
Time to progression of irradiated lesions
Time Frame
6 months
Title
Time to progression of GIST
Time Frame
6 months
Title
Control of GIST-related symptoms
Time Frame
6 months
Title
Adverse effects of radiation therapy
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically verified GIST.
Metastatic or locally advanced, inoperable disease.
Adequate systemic treatment has been administered.
One or more growing GIST metastasis present during of after TKI therapy.
The target lesion(s) is measurable.
A written informed consent
Exclusion Criteria:
WHO performance status is 4.
Estimated life-expectancy less than 3 months.
Radiation planning target volume greater than 3 dm3.
Unmeasurable target lesion. Bone and brain metastases are not accepted target lesions.
Radiation therapy cannot be delivered (e.g. active infection or restlessness.)
Pregnancy.
Systemic GIST treatment with unknown efficacy.
Copies of CT images cannot be sent for central review.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki Joensuu, M.D., Ph.D.
Organizational Affiliation
Department of Oncology, Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-00029
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26228971
Citation
Joensuu H, Eriksson M, Collan J, Balk MH, Leyvraz S, Montemurro M. Radiotherapy for GIST progressing during or after tyrosine kinase inhibitor therapy: A prospective study. Radiother Oncol. 2015 Aug;116(2):233-8. doi: 10.1016/j.radonc.2015.07.025. Epub 2015 Jul 27.
Results Reference
derived
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Radiation Therapy as Palliative Treatment of GIST
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