Clinical trial NCT00515931: Radiation Therapy as Palliative Treatment of GIST
Official title: Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sarcoma
Keywords: Gastrointestinal stromal tumor
GIST
Sarcoma
Radiation therapy
Radiotherapy
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Lund University
name: University of Lausanne Hospitals
First posted: 2007-08-14
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Target tumor response rate
timeFrame: 6 to 12 weeks
Secondary outcomes:
measure: Time to progression of irradiated lesions
timeFrame: 6 months
measure: Time to progression of GIST
timeFrame: 6 months
measure: Control of GIST-related symptoms
timeFrame: 6 months
measure: Adverse effects of radiation therapy
timeFrame: 6 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Department of Oncology, Helsinki University Central Hospital
name: Heikki Joensuu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.