NCT00515931

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 7, 2014

Status Verified

October 1, 2014

Enrollment Period

6.5 years

First QC Date

August 13, 2007

Last Update Submit

October 6, 2014

Conditions

Sarcoma

Keywords

Gastrointestinal stromal tumorGISTSarcomaRadiation therapyRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Target tumor response rate

    6 to 12 weeks

Secondary Outcomes (4)

  • Time to progression of irradiated lesions

    6 months

  • Time to progression of GIST

    6 months

  • Control of GIST-related symptoms

    6 months

  • Adverse effects of radiation therapy

    6 months

Study Arms (1)

Radiotherapy

EXPERIMENTAL

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

Radiation: Radiation therapy (external beam photons)

Interventions

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).

Also known as: Radiotherapy, fractionated radiation therapy
Radiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Related Publications (1)

  • Joensuu H, Eriksson M, Collan J, Balk MH, Leyvraz S, Montemurro M. Radiotherapy for GIST progressing during or after tyrosine kinase inhibitor therapy: A prospective study. Radiother Oncol. 2015 Aug;116(2):233-8. doi: 10.1016/j.radonc.2015.07.025. Epub 2015 Jul 27.

    PMID: 26228971DERIVED

MeSH Terms

Conditions

SarcomaGastrointestinal Stromal Tumors

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Connective TissueGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Heikki Joensuu, M.D., Ph.D.

    Department of Oncology, Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

August 1, 2007

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

October 7, 2014

Record last verified: 2014-10

Locations

FI(1)