Sarcoma
Conditions
Keywords
Gastrointestinal stromal tumor, GIST, Sarcoma, Radiation therapy, Radiotherapy
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.
Interventions
RADIATIONRadiation therapy (external beam photons)
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).
Sponsors
Lund University
University of Lausanne Hospitals
Heikki Joensuu
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target tumor response rate | 6 to 12 weeks |
Secondary
| Measure | 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 |
Countries
Finland
Outcome results
None listed