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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515931
First Posted: August 14, 2007
Last Update Posted: October 7, 2014
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.
Collaborators:
Lund University
University of Lausanne Hospitals
Information provided by (Responsible Party):
Heikki Joensuu, Helsinki University
  Purpose
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 Intervention Phase
Sarcoma Radiation: Radiation therapy (external beam photons) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Heikki Joensuu, Helsinki University:

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

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

Enrollment: 25
Study Start Date: August 2007
Study Completion Date: October 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00515931


Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, FIN-00029
Sponsors and Collaborators
Heikki Joensuu
Lund University
University of Lausanne Hospitals
Investigators
Principal Investigator: Heikki Joensuu, M.D., Ph.D. Department of Oncology, Helsinki University Central Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heikki Joensuu, Professor, Helsinki University
ClinicalTrials.gov Identifier: NCT00515931     History of Changes
Other Study ID Numbers: GIST-RT-2007
First Submitted: August 13, 2007
First Posted: August 14, 2007
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Heikki Joensuu, Helsinki University:
Gastrointestinal stromal tumor
GIST
Sarcoma
Radiation therapy
Radiotherapy

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms