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Radiation Therapy as Palliative Treatment of GIST (GIST-RT)
This study is currently recruiting participants.
Verified June 2011 by Helsinki University

First Received on August 13, 2007.   Last Updated on June 24, 2011   History of Changes
Sponsor: Helsinki University
Information provided by: Helsinki University
ClinicalTrials.gov Identifier: NCT00515931
  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 I
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Genetics Home Reference related topics: gastrointestinal stromal tumor
MedlinePlus related topics: Cancer Palliative Care Soft Tissue Sarcoma
U.S. FDA Resources

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Target tumor response rate [ Time Frame: 6 to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression of irradiated lesions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Time to progression of GIST [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Control of GIST-related symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adverse effects of radiation therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: August 2007
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2012 (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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00515931

Contacts
Contact: Heikki Joensuu, M.D., Ph.D. 947173208 ext 358 heikki.joensuu@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland, FIN-00029
Contact: Heikki Joensuu, M.D., Ph.D.     947173208 ext 358     heikki.joensuu@hus.fi    
Principal Investigator: Heikki Joensuu, M.D., Ph.D.            
Sponsors and Collaborators
Helsinki University
Investigators
Principal Investigator: Heikki Joensuu, M.D., Ph.D. Department of Oncology, Helsinki University Central Hospital
  More Information

No publications provided

Responsible Party: Heikki Joensuu, MD, Department of Oncology, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT00515931     History of Changes
Other Study ID Numbers: GIST-RT-2007
Study First Received: August 13, 2007
Last Updated: June 24, 2011
Health Authority: Finland: Ministry of Social Affairs and Health

Keywords provided by 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

ClinicalTrials.gov processed this record on February 09, 2012



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