Radiation Therapy as Palliative Treatment of GIST

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiotherapy

GIST patients who have progressing metastases will be treated with radiotherapy.

Group Type EXPERIMENTAL

Radiation therapy (external beam photons)

Intervention Type RADIATION

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).

Interventions

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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).

Intervention Type RADIATION

Other Intervention Names

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Radiotherapy, fractionated radiation therapy

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No