Clinical trial · Interventional
Radiation Therapy as Palliative Treatment of GIST
Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy (external beam photons) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiotherapy
- description
- GIST patients who have progressing metastases will be treated with radiotherapy.
- interventionNames
- Radiation: Radiation therapy (external beam photons)
Primary outcomes (1)
- measure
- Target tumor response rate
- timeFrame
- 6 to 12 weeks
Secondary outcomes (4)
- measure
- Time to progression of irradiated lesions
- timeFrame
- 6 months
- measure
- Time to progression of GIST
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJoensuu 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. PMID 26228971