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NCT Number: NCT00515931

Radiation Therapy as Palliative Treatment of GIST

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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Key information

Conditions

Sarcoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiation therapy (external beam photons)

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).

Other names: Radiotherapy, fractionated radiation therapy

Primary outcomes

  1. Target tumor response rate

    Time frame: 6 to 12 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Heikki Joensuu

Other

Collaborators

  • Lund University
  • University of Lausanne Hospitals

Registry information

Official study title

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

Acronym: GIST-RT

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Aug 14, 2007
Registry last updated
Oct 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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