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A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.

Phase 3
18 Years
Not Enrolling
Gastrointestinal Stromal Tumor

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Trial Information

A Phase III Randomized Study Evaluating Surgery of Residual Disease in Patients With Metastatic Gastro-intestinal Stromal Tumor Responding to Imatinib Mesylate.



- Evaluate whether surgery of residual disease improves the progression-free survival of
patients with metastatic gastrointestinal stromal tumor responding to imatinib


- 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.

Inclusion Criteria


- 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


- 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

- 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


- See Disease Characteristics

- No prior adjuvant or neo-adjuvant imatinib mesylate or other tyrosine kinase

- 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

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:


Principal Investigator

Alessandro Gronchi

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Nazionale per lo Studio e la Cura dei Tumori


United States: Federal Government

Study ID:




Start Date:

May 2009

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • gastrointestinal stromal tumor
  • Gastrointestinal Stromal Tumors