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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in Italy

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.

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.

Study groups in NCT00956072
Study groupRoleWhat they receive
Arm IExperimentalPatients undergo surgery of residual disease.
Receives: Procedure: therapeutic conventional surgery
Arm IIActive comparatorPatients 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.

  1. Progression-free survival

Secondary outcomes (5)
  1. Overall survival

  2. Pathological response to imatinib mesylate according to RECIST criteria

  3. Rate of complete resection

  4. Surgical morbidity

  5. 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.

  1. First posted11 Aug 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMar 2011

Why it stopped: low accrual

Resources

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)
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

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.

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