Radiation Therapy as Palliative Treatment of GIST

Sarcoma Clinical Trial

— GIST-RT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00515931
• Other study ID #: GIST-RT-2007
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 13, 2007
• Last updated: October 6, 2014
• Start date: August 2007
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Radiation:
• Radiation 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).

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Heikki Joensuu	Lund University, University of Lausanne Hospitals

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target tumor response rate		6 to 12 weeks	No
Secondary	Time to progression of irradiated lesions		6 months	No
Secondary	Time to progression of GIST		6 months	No
Secondary	Control of GIST-related symptoms		6 months	No
Secondary	Adverse effects of radiation therapy		6 months	Yes