Radiation Therapy as Palliative Treatment of GIST

Study Overview
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Brief Summary
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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
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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.

Official Title
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Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study

Conditions
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Sarcoma

Intervention / Treatment
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* Radiation: Radiation therapy (external beam photons)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy<br>GIST patients who have progressing metastases will be treated with radiotherapy. | Radiation: Radiation therapy (external beam photons)<br>* 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).<br>* Other names: Radiotherapy, fractionated radiation therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target tumor response rate |  | 6 to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression of irradiated lesions |  | 6 months | 
| Time to progression of GIST |  | 6 months | 
| Control of GIST-related symptoms |  | 6 months | 
| Adverse effects of radiation therapy |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal stromal tumor, GIST, Sarcoma, Radiation therapy, Radiotherapy