Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
N/A
N/A
Both
Sarcoma
Trial Information
Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Target tumor response rate
Outcome Time Frame:
6 to 12 weeks
Safety Issue:
No
Principal Investigator
Heikki Joensuu, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Oncology, Helsinki University Central Hospital
Authority:
Finland: Ministry of Social Affairs and Health
Study ID:
GIST-RT-2007
NCT ID:
NCT00515931
Start Date:
August 2007
Completion Date:
August 2013
Related Keywords:
- Sarcoma
- Gastrointestinal stromal tumor
- GIST
- Sarcoma
- Radiation therapy
- Radiotherapy
- Sarcoma
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