SarcomaPhase 1/2GIST-RTNCT00515931
Radiation Therapy as Palliative Treatment of GIST
A Phase 1/2 study testing Radiation therapy (external beam photons) in people with Sarcoma, run by Heikki Joensuu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sarcoma
- What is being tested?
- Radiation therapy (external beam photons)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2007to Oct 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- Radiation therapy (external beam photons)
- Keywords
- Gastrointestinal stromal tumor, GIST, Sarcoma, Radiation therapy, Radiotherapy
- Medical subject headings
- Sarcoma, Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapy (external beam photons)Radiation
Also called Radiotherapy, fractionated radiation therapy
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).
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | GIST patients who have progressing metastases will be treated with radiotherapy. Receives: Radiation: Radiation therapy (external beam photons) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target tumor response rate
Measured: 6 to 12 weeks
Secondary outcomes (4)
Time to progression of irradiated lesions
Measured: 6 months
Time to progression of GIST
Measured: 6 months
Control of GIST-related symptoms
Measured: 6 months
Adverse effects of radiation therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionFeb 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heikki Joensuu
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, University of Lausanne Hospitals
- Responsible party
- Sponsor-investigator, Heikki Joensuu, University of Helsinki
- Investigators
- Heikki Joensuu, M.D., Ph.D., Principal investigator, Department of Oncology, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515931
- Sponsor's protocol ID
- GIST-RT-2007
- Acronym
- GIST-RT
- Status last verified
- Oct 2014
- First submitted
- 13 Aug 2007
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26228971
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Therapy as Palliative Treatment of GIST Progressing During or After Tyrosine Kinase Inhibitor Therapy: A Prospective Study
- ClinicalTrials.gov ID
- NCT00515931
- Acronym / sponsor ID
- GIST-RT / GIST-RT-2007
- Conditions
- Sarcoma
- Keywords
- Gastrointestinal stromal tumor, GIST, Sarcoma, Radiation therapy, Radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Heikki JoensuuUniversity, hospital or other
- Collaborators
- Lund University, University of Lausanne Hospitals
- Study start
- Aug 2007
- Primary completion
- Feb 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Radiation therapy (external beam photons)GIST patients who have progressing metastases will be treated with radiotherapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapy (external beam photons)Also: Radiotherapy, fractionated radiation therapyA 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). | Radiation | Radiotherapy |
Primary outcome
Target tumor response rate
Time frame: 6 to 12 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2014.
- Derived from this study: PubMed 26228971Joensuu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki Joensuu, M.D., Ph.D. principal investigator
Department of Oncology, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiation therapy (external beam photons) in people with Sarcoma, run by Heikki Joensuu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target tumor response rate (time frame: 6 to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00515931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2014.