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Radiation Therapy as Palliative Treatment of GIST (GIST-RT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00515931
Recruitment Status : Completed
First Posted : August 14, 2007
Last Update Posted : October 7, 2014
Lund University
University of Lausanne Hospitals
Information provided by (Responsible Party):
Heikki Joensuu, University of Helsinki

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.

Condition or disease Intervention/treatment Phase
Sarcoma Radiation: Radiation therapy (external beam photons) Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
Study Start Date : August 2007
Actual Primary Completion Date : February 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Experimental: Radiotherapy
GIST patients who have progressing metastases will be treated with radiotherapy.
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).
Other Name: Radiotherapy, fractionated radiation therapy

Primary Outcome Measures :
  1. Target tumor response rate [ Time Frame: 6 to 12 weeks ]

Secondary Outcome Measures :
  1. Time to progression of irradiated lesions [ Time Frame: 6 months ]
  2. Time to progression of GIST [ Time Frame: 6 months ]
  3. Control of GIST-related symptoms [ Time Frame: 6 months ]
  4. Adverse effects of radiation therapy [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00515931

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Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
Sponsors and Collaborators
Heikki Joensuu
Lund University
University of Lausanne Hospitals
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Principal Investigator: Heikki Joensuu, M.D., Ph.D. Department of Oncology, Helsinki University Central Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Heikki Joensuu, Professor, University of Helsinki Identifier: NCT00515931    
Other Study ID Numbers: GIST-RT-2007
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014
Keywords provided by Heikki Joensuu, University of Helsinki:
Gastrointestinal stromal tumor
Radiation therapy
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type