Clinical trial · Interventional
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor
Phase II Multicenter Clinical Trial on Surgery for Patients With Resectable Hepatic Metastasis From Gastrointestinal Stromal Tumors (GISTs)
NCT00769782CI-TRIAL-00068164GISTscompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor. PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Stromal Tumor | Gastrointestinal Stromal Tumor | ONTOLOGY_EXACT | 0.98 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- therapeutic conventional surgery
- description
- All patients undergo suegery to achieve macroscopic complete resection within 28 days after enrollment (including enrollment day). As long as tumor free margin is ensured, all resection margin distances and all surgical procedure are accepted. Surgical treatment in this study excludes the following, radiofrequency ablation (RFA) without resection of liver only or microwave coagulation therapy (MCT) only; for RFA or MCT is used as additional treatment under judgment of primary physician for new liver tumor which comfirmed during surgery in different parts of liver except portion scheduled for resection, RFA and MCT are included. After histological curative resection, patients are observed without treatment until comfirming recurrence. Patients with incomplete tumor removal are withdrawn from protcol treatment and receive imatinib treatment, 400 mg/day orally. For reccurrence is comfirmed, patients receive imatinib treatment, 400 mg/day orally.
- interventionNames
- Procedure: therapeutic conventional surgery
Primary outcomes (1)
- measure
- Recurrence-free survival
- timeFrame
- 7.5 years
- description
- Recurrence-free survival is defined as time from date of surgery until date of recurrence or death from any cause, whichever comes first.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of gastrointestinal stromal tumor (GIST) * Hepatic metastasis meeting the following criteria: * Clinically diagnosed as surgically resectable with no macroscopic residual tumor * No more than 3 hepatic metastases * Synchronous hepatic metastasis allowed provided primary tumor is also resectable * Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease * No extrahepatic metastasis * No history of GIST recurrence PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Leukocyte count ≥ 3,000/μL * Neutrophil count ≥ 1,500/μL * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 75,000/μL * Total bilirubin ≤ 2.0 mg/dL * ALT and AST \< 120 IU/L * GTP \< 210 IU/L * Not pregnant * No poorly controlled diabetes mellitus * No NYHA class III-IV cardiac function * No hepatitis B or hepatitis B carriers * No other malignancy requiring treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior interventional radiology for metastatic disease * No prior or concurrent imatinib mesylate * No other concurrent treatment
References
Publications (0)
Data not yet available
No reference posted for this study.