Gastrointestinal Stromal TumorPhase 3NCT00956072
Imatinib Mesylate With or Without Surgery in Treating Patients With Metastatic Gastrointestinal Stromal Tumor That is Responding to Imatinib Mesylate
A Phase 3 study testing imatinib mesylate and therapeutic conventional surgery in people with Gastrointestinal Stromal Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Italy.
Trial summary
RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than continued imatinib mesylate in treating patients with metastatic gastrointestinal stromal tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor
- What is being tested?
- imatinib mesylate and therapeutic conventional surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- May 2009to Mar 2011
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed gastrointestinal stromal tumor expressing CD117+ or with documented mutation of the KIT or PDGFRA gene
- Metastatic disease (liver and/or abdominal cavity)
- No extra-abdominal metastases
- Measurable disease according to RECIST criteria
- Achieved complete response, partial response, or stable disease without progression since the start of imatinib mesylate therapy, documented according to RECIST
- Underwent 6-12 months of treatment with imatinib mesylate as a standard of care or within other clinical studies (surgery should be feasible before the end of the 12th month from imatinib mesylate onset)
- Surgically resectable residual disease as assessed by CT scan and/or MRI within the past 14 days
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine < 120 μmol/L
- Albumin > 25 g/L
- Total bilirubin < 2 times upper limit of normal (ULN)
- AST and ALT < 2.5 times ULN (< 5 ULN in case of liver metastases)
- Alkaline phosphatase < 2.5 times ULN (< 5 ULN in case of bone or liver metastases)
- Negative pregnancy test within the past 14 days
- Fertile patients must use effective contraception
- No uncontrolled hypertension (diastolic BP > 95 mm Hg and systolic BP > 170 mm Hg)
- No myocardial infarction, unstable, or uncontrolled cardiac disease within the past 6 months
- No history of arterial thrombosis or deep vein thrombosis within the past year
- No bleeding diathesis, coagulopathy, or major bleeding within the past 6 months
- No severe and/or uncontrolled concurrent medical disease, including any of the following conditions:
- Diabetes
- Chronic renal disease
- Liver disease, including chronic viral hepatitis judged at risk of reactivation
- Active infection, including HIV infection
- No prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal cell or squamous cell cancer of the skin) unless treated with curative intent and without evidence of disease for at least 3 years
- No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior adjuvant or neo-adjuvant imatinib mesylate or other tyrosine kinase inhibitor
- No coumadin-type anticoagulant > 2mg/day within the past 7 days
- No major surgery within the past 28 days
- No medication that interacts moderately or strongly with the CYP3A system within the past 14 days
Trial locations and contacts
1 site in 1 country.
Italy1 site
European Organization for Research and Treatment of Cancer
Naples, 80131
About this study
Official title: A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.
RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than continued imatinib mesylate in treating patients with metastatic gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy together with surgery to see how well it works compared with imatinib mesylate alone in treating patients with metastatic gastrointestinal stromal tumor that is responding to imatinib mesylate.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate whether surgery of residual disease improves the progression-free survival of patients with metastatic gastrointestinal stromal tumor responding to imatinib mesylate.
Secondary
- Correlate the pharmacokinetics of imatinib mesylate and its metabolites before and after randomization.
OUTLINE: This is a multicenter study. Patients are stratified according to center, site of tumor origin (stomach vs small bowel vs others), and site of metastases (liver vs abdominal cavity vs both). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgery of residual disease. Patients will then resume imatinib mesylate therapy according to standard of care as soon as possible after surgery (as soon as the patient restarts taking oral feeding).
- Arm II: Patients receive imatinib mesylate therapy according to standard of care.
Patients complete quality of life questionnaires at baseline; immediately after hospital discharge (arm I only); and at 5, 11, and 23 months. Blood samples may be collected for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 5 years and then every 6 months.
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- imatinib mesylate, therapeutic conventional surgery
- Keywords
- gastrointestinal stromal tumor
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Patients receive imatinib mesylate
therapeutic conventional surgeryProcedure or surgery
Patients undergo surgery
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo surgery of residual disease. Receives: Procedure: therapeutic conventional surgery |
| Arm II | Active comparator | Patients receive imatinib mesylate therapy according to standard of care. Receives: Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Secondary outcomes (5)
Overall survival
Pathological response to imatinib mesylate according to RECIST criteria
Rate of complete resection
Surgical morbidity
Quality of life as measured by EORTC QLQ-C30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2011
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alessandro Gronchi, Principal investigator, Istituto Nazionale per lo Studio e la Cura dei Tumori
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956072
- Sponsor's protocol ID
- EORTC-62063
- Other IDs
- EORTC-62063, EU-20955, EUDRACT-2007-002257-23, NOVARTIS-EORTC-62063
- Status last verified
- Sep 2012
- First submitted
- 8 Aug 2009
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.
- ClinicalTrials.gov ID
- NCT00956072
- Acronym / sponsor ID
- EORTC-62063
- Conditions
- Gastrointestinal Stromal Tumor
- Keywords
- gastrointestinal stromal tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2009
- Primary completion
- Mar 2011 (actual)
- First posted
- 11 Aug 2009 (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.
RATIONALE: Surgery may remove residual disease in patients with gastrointestinal stromal tumor that is responding to imatinib mesylate. It is not yet known whether surgery is more effective than continued imatinib mesylate in treating patients with metastatic gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying giving imatinib mesylate therapy together with surgery to see how well it works compared with imatinib mesylate alone in treating patients with metastatic gastrointestinal stromal tumor that is responding to imatinib mesylate.
Detailed description
OBJECTIVES:
Primary
- Evaluate whether surgery of residual disease improves the progression-free survival of patients with metastatic gastrointestinal stromal tumor responding to imatinib mesylate.
Secondary
- Correlate the pharmacokinetics of imatinib mesylate and its metabolites before and after randomization.
OUTLINE: This is a multicenter study. Patients are stratified according to center, site of tumor origin (stomach vs small bowel vs others), and site of metastases (liver vs abdominal cavity vs both). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo surgery of residual disease. Patients will then resume imatinib mesylate therapy according to standard of care as soon as possible after surgery (as soon as the patient restarts taking oral feeding).
- Arm II: Patients receive imatinib mesylate therapy according to standard of care.
Patients complete quality of life questionnaires at baseline; immediately after hospital discharge (arm I only); and at 5, 11, and 23 months. Blood samples may be collected for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 5 years and then every 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Procedure: therapeutic conventional surgeryPatients undergo surgery of residual disease. |
| Arm II | Active comparator | Drug: imatinib mesylatePatients receive imatinib mesylate therapy according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| imatinib mesylatePatients receive imatinib mesylate | Drug | Arm II |
| therapeutic conventional surgeryPatients undergo surgery | Procedure or surgery | Arm I |
Primary outcome
Progression-free survival
5 secondary outcomes
Overall survival
Pathological response to imatinib mesylate according to RECIST criteria
Rate of complete resection
Surgical morbidity
Quality of life as measured by EORTC QLQ-C30
Results and safety
The study was stopped early (reason given: low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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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.
Alessandro Gronchi principal investigator
Istituto Nazionale per lo Studio e la Cura dei Tumori
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing imatinib mesylate and therapeutic conventional surgery in people with Gastrointestinal Stromal Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 24 Sep 2012. 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 Italy. 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 was stopped early (reason given: low accrual). Results are not available in the source record.
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2012.