SarcomaPhase 3NCT00367861
Prospective Multicentric Randomized Study of Glivec® in Advanced GIST Expressing C-kit: Interruption After 5 Years vs Maintenance
A Phase 3 study testing interruption of Glivec® in people with Sarcoma and Gastro-intestinal Stromal Tumors (GIST), run by Centre Leon Berard at 8 sites in France.
Trial summary
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma, Gastro-intestinal Stromal Tumors (GIST)
- What is being tested?
- interruption of Glivec®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 564 participants
- Where
- 8 sitesFrance
- Study dates
- May 2002to May 2013
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or over.
- Histologically documented diagnosis of malignant GIST.
- Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.
- Performance status 0,1, 2, 3 (ECOG)
- Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.0 x 109/L, platelets > 100 x 109/L.
- Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 2 weeks (according to updated Invest. Brochure) following discontinuation of study drug.
- Written, voluntary, informed consent.
Who cannot join
- Patient has another malignant tumor in CR<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are allowed.
- Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- Female patients who are pregnant or breast-feeding.
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing
- Patients had a major surgery within 2 weeks prior to entry study
- Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- Previous treatment with Glivec®
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Institut Bergonié
Bordeaux, 33000
Centre Oscar Lambret
Lille, 59000
Centre Leon Berard
Lyon, 69008
Hopital Edouard Herriot
Lyon, 69008
Hopitaux de La Timone
Marseille, 13000
Institut Paoli Calmette
Marseille, 13000
Centre Alexis Vautrin
Nancy, 57000
Institut Gustave Roussy
Villejuif, 94850
About this study
Official title: A Prospective Multicentric Randomized Study of Glivec® in Patients With Advanced Gastrointestinal Stromal Tumors Expressing C-kit Comparing Treatment Interruption After 5 Years vs Treatment Maintenance
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.
Read the detailed description
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. GIST cells are positive for KIT (CD117) and CD34 in 100% and 70% of cases, respectively. Virtually all malignant GISTs actually harbor activating mutations of the kit pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT activity at an IC50 of approximately 100 nM which is similar to that required for inhibiting the tyrosine kinase associated with Bcr-abl and the PDGF receptor. Experiments on cell lines containing an activating juxtamembrane mutation (similar to that found in GISTs) and cell lines containing transfected wild type KIT protein, showed that these cells appear to be strongly dependent upon the activity of the mutant receptor to prevent apoptosis, thus providing further scientific justification for the development of Glivec® as an antineoplastic agent with specific activity against GIST as a KIT-driven malignancy.
Since the first single patient with metastatic GIST treated by Glivec® in March 2000 (16), more than 2000 patients have been included in prospective trials testing activity and tolerance of Glivec® in patients with advanced/metastatic GIST. High response rates have been documented, only a limited percentage of patients progressed after achieving objective response, and median survival has not been reached in all studies. There has been no clear demonstration of a dose-response relationship. About 15% of patients experienced a rapid disease progression under treatment but the mechanisms of resistance remain unknown. Some patients progressing at 400 mg/day further responded to higher doses of Glivec®. Toxicities were infrequent, mainly mild to moderate and their incidence seems to be related to the total daily dose administered.
The optimal duration of treatment with Glivec® remains unknown. In addition the impact of surgical procedures of tumoral residual masses is not yet evaluated on progression free and overall survival. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.
Primary objective
- To compare progression-free overall survival beyond 1 year in patients treated by Glivec® achieving a CR, PR or SD at 5 years. Patients will be randomized between 1) interruption of Glivec® until progression w/ RECIST criteria and then re-start (group 1) vs 2) maintenance of Glivec® (group 2).
Secondary objectives
- To compare overall survival in the two groups of randomized patients.
- To determine progression free survival beyond 1 year in patients in CR, PR or SD at 5 years who refused randomization and 1) selected Glivec® interruption or 2) chose Glivec® maintenance.
- To determine CR, PR and SD rates after re-start of Glivec® in group 1.
- To assess the number of patients who completed radical surgery on tumour residual masses after an objective response.
- To assess resource utilisation by evaluating direct and indirect cost.
- To evaluate the correlation between the serum rates of Glivec® and the response to the treatment w/ RECIST criteria, in patients with the diagnosis of GIST and treated by Glivec® 400mg /day, and this until progression, stop treatment or study exit.
- To follow immune modifications induced by Glivec® administration potentially related to clinical response and toxicity.
- To realize if possible the sequencing with aiming diagnoses KIT, in order to evaluate the correlations existing between the response/or the absence of response to Glivec® and the type of mutation of KIT.
Overall study design : This is an open label clinical trial of oral Glivec® 400 mg/day in a population of patients with metastatic and/or unresectable malignant GIST in relapse. 564 patients will be enrolled in ten years in 20-30 French Cooperative Centers.
Treatment : Patients will receive Glivec® 400 mg /day for an exposure period of 60 months. At the end of a 5 years period, patients with non progressive disease will be proposed for randomization between 1) interruption of Glivec® until progression w/ RECIST criteria and then re-start vs 2) maintenance of Glivec®. Patient who refuse randomization will be proposed either solution and followed according to the same schedule. During treatment with Glivec® 400mg/day, Glivec® may be increased to 600 mg/day or 800 mg/day if the patient is progressing. In case of re-progression, the patient will be excluded of this study.
Signed informed consent for the study, including the possible randomization, will be obtained.
- Conditions
- Sarcoma, Gastro-intestinal Stromal Tumors (GIST)
- Being tested
- interruption of Glivec®
- Keywords
- GIST, Glivec®, randomized, phase III
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interruption of Glivec®Drug
interruption of Glivec®
| Study group | Role | What they receive |
|---|---|---|
| interruption of Glivec® | Experimental | Not described Receives: Drug: interruption of Glivec® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
to compare progression free survival beyond 2 years in patients treated by Glivec® achieving a CR, PR or SD at 5 years. Patients will be randomized either interruption of Glivec® until progression w/RECIST criteria and the re-start (group 1) or(/vs) maintenance of Glivec® (group 2).
Measured: 2 years
Secondary outcomes (2)
Overall survival
To compare overall survival beyond 2 years in the two groups of randomized patients.
Measured: 2 years
Toxicity
Evaluation of toxicity during inclusion in the study
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2006 (estimated)
- Study startMay 2002
- Primary completionApr 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Responsible party
- Sponsor
- Investigators
- Jean Yves Blay, M.D., Ph.D, Principal investigator, Centre Leon Berard, INSERM U590 & Hopital Edouard HerriotAxel Le Cesne, M.D., Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00367861
- Sponsor's protocol ID
- CST1571BFR14
- Other IDs
- ET2002-021
- Status last verified
- Feb 2014
- First submitted
- 21 Aug 2006
- Last updated
- 24 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Perol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.
PubMed 20864406Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13. doi: 10.1200/JCO.2006.09.0183.
PubMed 17369574Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Perol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.
PubMed 23175622Blesius A, Cassier PA, Bertucci F, Fayette J, Ray-Coquard I, Bui B, Adenis A, Rios M, Cupissol D, Perol D, Blay JY, Le Cesne A. Neoadjuvant imatinib in patients with locally advanced non metastatic GIST in the prospective BFR14 trial. BMC Cancer. 2011 Feb 15;11:72. doi: 10.1186/1471-2407-11-72.
PubMed 21324142Blay JY, Perol D, Le Cesne A. Imatinib rechallenge in patients with advanced gastrointestinal stromal tumors. Ann Oncol. 2012 Jul;23(7):1659-65. doi: 10.1093/annonc/mdr622. Epub 2012 Feb 21.
PubMed 22357253Blay JY, Devin Q, Duffaud F, Toulmonde M, Firmin N, Collard O, Bompas E, Verret B, Ray-Coquard I, Salas S, Henon C, Honore C, Brahmi M, Dufresne A, Pracht M, Hervieu A, Penel N, Bertucci F, Rios M, Saada-Bouzid E, Soibinet P, Perol D, Chabaud S, Italiano A, Cesne AL. Discontinuation versus continuation of imatinib in patients with advanced gastrointestinal stromal tumours (BFR14): exploratory long-term follow-up of an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2024 Sep;25(9):1163-1175. doi: 10.1016/S1470-2045(24)00318-8. Epub 2024 Aug 7.
PubMed 39127063Patrikidou A, Domont J, Chabaud S, Ray-Coquard I, Coindre JM, Bui-Nguyen B, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Perol D, Emile JF, Blay JY, Le Cesne A; French Sarcoma Group. Long-term outcome of molecular subgroups of GIST patients treated with standard-dose imatinib in the BFR14 trial of the French Sarcoma Group. Eur J Cancer. 2016 Jan;52:173-80. doi: 10.1016/j.ejca.2015.10.069. Epub 2015 Dec 11.
PubMed 26687836
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentric Randomized Study of Glivec® in Patients With Advanced Gastrointestinal Stromal Tumors Expressing C-kit Comparing Treatment Interruption After 5 Years vs Treatment Maintenance
- ClinicalTrials.gov ID
- NCT00367861
- Acronym / sponsor ID
- CST1571BFR14
- Conditions
- Sarcoma, Gastro-intestinal Stromal Tumors (GIST)
- Keywords
- GIST, Glivec®, randomized, phase III
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- Gustave Roussy, Cancer Campus, Grand Paris
- Study start
- May 2002
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Aug 2006 (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 associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. Virtually all malignant GISTs actually harbor activating mutations of the KIT pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT and exerts a major antitumor efficacy in vivo in patients with advanced GIST. Glivec® is generally pursued until progression or intolerance. The optimal duration of treatment with Glivec® remains unknown. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.
Detailed description
Gastrointestinal stromal tumors (GISTs) are associated with a dismal prognosis in localized and advanced phase with a major resistance to conventional chemotherapy agents. GIST cells are positive for KIT (CD117) and CD34 in 100% and 70% of cases, respectively. Virtually all malignant GISTs actually harbor activating mutations of the kit pathway in the tumor cells, leading to ligand-independent activation of KIT tyrosine kinase activity and tumor growth in vitro. Glivec® inhibits KIT activity at an IC50 of approximately 100 nM which is similar to that required for inhibiting the tyrosine kinase associated with Bcr-abl and the PDGF receptor. Experiments on cell lines containing an activating juxtamembrane mutation (similar to that found in GISTs) and cell lines containing transfected wild type KIT protein, showed that these cells appear to be strongly dependent upon the activity of the mutant receptor to prevent apoptosis, thus providing further scientific justification for the development of Glivec® as an antineoplastic agent with specific activity against GIST as a KIT-driven malignancy.
Since the first single patient with metastatic GIST treated by Glivec® in March 2000 (16), more than 2000 patients have been included in prospective trials testing activity and tolerance of Glivec® in patients with advanced/metastatic GIST. High response rates have been documented, only a limited percentage of patients progressed after achieving objective response, and median survival has not been reached in all studies. There has been no clear demonstration of a dose-response relationship. About 15% of patients experienced a rapid disease progression under treatment but the mechanisms of resistance remain unknown. Some patients progressing at 400 mg/day further responded to higher doses of Glivec®. Toxicities were infrequent, mainly mild to moderate and their incidence seems to be related to the total daily dose administered.
The optimal duration of treatment with Glivec® remains unknown. In addition the impact of surgical procedures of tumoral residual masses is not yet evaluated on progression free and overall survival. The objective of this study is to determine the feasibility of Glivec® treatment interruption with reintroduction at progression in GIST patients.
Primary objective
- To compare progression-free overall survival beyond 1 year in patients treated by Glivec® achieving a CR, PR or SD at 5 years. Patients will be randomized between 1) interruption of Glivec® until progression w/ RECIST criteria and then re-start (group 1) vs 2) maintenance of Glivec® (group 2).
Secondary objectives
- To compare overall survival in the two groups of randomized patients.
- To determine progression free survival beyond 1 year in patients in CR, PR or SD at 5 years who refused randomization and 1) selected Glivec® interruption or 2) chose Glivec® maintenance.
- To determine CR, PR and SD rates after re-start of Glivec® in group 1.
- To assess the number of patients who completed radical surgery on tumour residual masses after an objective response.
- To assess resource utilisation by evaluating direct and indirect cost.
- To evaluate the correlation between the serum rates of Glivec® and the response to the treatment w/ RECIST criteria, in patients with the diagnosis of GIST and treated by Glivec® 400mg /day, and this until progression, stop treatment or study exit.
- To follow immune modifications induced by Glivec® administration potentially related to clinical response and toxicity.
- To realize if possible the sequencing with aiming diagnoses KIT, in order to evaluate the correlations existing between the response/or the absence of response to Glivec® and the type of mutation of KIT.
Overall study design : This is an open label clinical trial of oral Glivec® 400 mg/day in a population of patients with metastatic and/or unresectable malignant GIST in relapse. 564 patients will be enrolled in ten years in 20-30 French Cooperative Centers.
Treatment : Patients will receive Glivec® 400 mg /day for an exposure period of 60 months. At the end of a 5 years period, patients with non progressive disease will be proposed for randomization between 1) interruption of Glivec® until progression w/ RECIST criteria and then re-start vs 2) maintenance of Glivec®. Patient who refuse randomization will be proposed either solution and followed according to the same schedule. During treatment with Glivec® 400mg/day, Glivec® may be increased to 600 mg/day or 800 mg/day if the patient is progressing. In case of re-progression, the patient will be excluded of this study.
Signed informed consent for the study, including the possible randomization, will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interruption of Glivec® | Experimental | Drug: interruption of Glivec® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years of age or over.
- Histologically documented diagnosis of malignant GIST.
- Immunohistochemical documentation of c-kit (CD117) expression either by the primary tumor or metastases using the DAKO assay.
- Performance status 0,1, 2, 3 (ECOG)
- Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL (or < 5 x ULN if hepatic metastases are present), creatinine < 1.5 x ULN, ANC > 1.0 x 109/L, platelets > 100 x 109/L.
Key exclusion criteria (8 listed)
- Patient has another malignant tumor in CR<3 years (except if the other primary malignancy is inactive and not requiring active intervention). Previous basal cell skin cancer or a cervical carcinoma in situ are allowed.
- Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
- Female patients who are pregnant or breast-feeding.
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patients received chemotherapy within 2 weeks prior to study entry, unless the disease is rapidly progressing
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 |
|---|---|---|
| interruption of Glivec®interruption of Glivec® | Drug | interruption of Glivec® |
Primary outcome
Progression free survival
Time frame: 2 years
to compare progression free survival beyond 2 years in patients treated by Glivec® achieving a CR, PR or SD at 5 years. Patients will be randomized either interruption of Glivec® until progression w/RECIST criteria and the re-start (group 1) or(/vs) maintenance of Glivec® (group 2).
2 secondary outcomes
Overall survival
Time frame: 2 years
Toxicity
Time frame: 7 years
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 24 Feb 2014.
- Background: PubMed 20864406Le Cesne A, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Cioffi A, Emile JF, Chabaud S, Perol D, Blay JY; French Sarcoma Group. Discontinuation of imatinib in patients with advanced gastrointestinal stromal tumours after 3 years of treatment: an open-label multicentre randomised phase 3 trial. Lancet Oncol. 2010 Oct;11(10):942-9. doi: 10.1016/S1470-2045(10)70222-9. Epub 2010 Sep 21.
- Background: PubMed 17369574Blay JY, Le Cesne A, Ray-Coquard I, Bui B, Duffaud F, Delbaldo C, Adenis A, Viens P, Rios M, Bompas E, Cupissol D, Guillemet C, Kerbrat P, Fayette J, Chabaud S, Berthaud P, Perol D. Prospective multicentric randomized phase III study of imatinib in patients with advanced gastrointestinal stromal tumors comparing interruption versus continuation of treatment beyond 1 year: the French Sarcoma Group. J Clin Oncol. 2007 Mar 20;25(9):1107-13. doi: 10.1200/JCO.2006.09.0183.
- Background: PubMed 23175622Patrikidou A, Chabaud S, Ray-Coquard I, Bui BN, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Domont J, Perol D, Blay JY, Le Cesne A; French Sarcoma Group. Influence of imatinib interruption and rechallenge on the residual disease in patients with advanced GIST: results of the BFR14 prospective French Sarcoma Group randomised, phase III trial. Ann Oncol. 2013 Apr;24(4):1087-93. doi: 10.1093/annonc/mds587. Epub 2012 Nov 21.
- Background: PubMed 21324142Blesius A, Cassier PA, Bertucci F, Fayette J, Ray-Coquard I, Bui B, Adenis A, Rios M, Cupissol D, Perol D, Blay JY, Le Cesne A. Neoadjuvant imatinib in patients with locally advanced non metastatic GIST in the prospective BFR14 trial. BMC Cancer. 2011 Feb 15;11:72. doi: 10.1186/1471-2407-11-72.
- Background: PubMed 22357253Blay JY, Perol D, Le Cesne A. Imatinib rechallenge in patients with advanced gastrointestinal stromal tumors. Ann Oncol. 2012 Jul;23(7):1659-65. doi: 10.1093/annonc/mdr622. Epub 2012 Feb 21.
- Derived from this study: PubMed 39127063Blay JY, Devin Q, Duffaud F, Toulmonde M, Firmin N, Collard O, Bompas E, Verret B, Ray-Coquard I, Salas S, Henon C, Honore C, Brahmi M, Dufresne A, Pracht M, Hervieu A, Penel N, Bertucci F, Rios M, Saada-Bouzid E, Soibinet P, Perol D, Chabaud S, Italiano A, Cesne AL. Discontinuation versus continuation of imatinib in patients with advanced gastrointestinal stromal tumours (BFR14): exploratory long-term follow-up of an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2024 Sep;25(9):1163-1175. doi: 10.1016/S1470-2045(24)00318-8. Epub 2024 Aug 7.
- Derived from this study: PubMed 26687836Patrikidou A, Domont J, Chabaud S, Ray-Coquard I, Coindre JM, Bui-Nguyen B, Adenis A, Rios M, Bertucci F, Duffaud F, Chevreau C, Cupissol D, Perol D, Emile JF, Blay JY, Le Cesne A; French Sarcoma Group. Long-term outcome of molecular subgroups of GIST patients treated with standard-dose imatinib in the BFR14 trial of the French Sarcoma Group. Eur J Cancer. 2016 Jan;52:173-80. doi: 10.1016/j.ejca.2015.10.069. Epub 2015 Dec 11.
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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.
Jean Yves Blay, M.D., Ph.D principal investigator
Centre Leon Berard, INSERM U590 & Hopital Edouard Herriot
Axel Le Cesne, M.D. principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing interruption of Glivec® in people with Sarcoma and Gastro-intestinal Stromal Tumors (GIST), run by Centre Leon Berard at 8 sites in France.
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 7 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 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Progression free survival (time frame: 2 years). 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 NCT00367861, which also lists 7 linked publications.
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 24 Feb 2014.