Clinical trial · Interventional
Chemotherapy With or Without Isolated Hepatic Perfusion With Melphalan in Treating Patients With Colorectal Cancer That Has Spread to the Liver
A Phase III Prospective Random Assignment Trial of Regional and Systemic Chemotherapy With or Without Initial Isolated Hepatic Perfusion for Patients With Metastatic Unresectable Colorectal Cancers of the Liver
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known which chemotherapy regimen is most effective for colorectal cancer that has spread to the liver. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without isolated hepatic perfusion with melphalan in treating patients who have colorectal cancer that has spread to the liver.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| floxuridine | Drug | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| hyperthermia treatment | Procedure | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic colorectal cancer of the parenchyma of the liver * No evidence of extrahepatic disease (limited resectable extrahepatic disease allowed) * Unresectable liver metastasis, as defined by the following: * More than 3 sites of disease * Bilobar disease * Tumor abutting major vascular or ductal structures * Measurable disease * No biopsy-proven cirrhosis or evidence of significant portal hypertension manifested by ascites, esophageal varices, or collateral vessels around organs drained by the portal venous system PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Hematocrit greater than 27.0% * WBC greater than 3,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * PT no greater than 2 seconds over upper limit of normal * Elevations in transaminases secondary to metastatic disease allowed * No veno-occlusive disease * No active chronic hepatitis * Hepatitis B or C allowed provided there is no evidence of cirrhosis Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance greater than 60 mL/min Cardiovascular: * No ischemic cardiac disease * No prior congestive heart failure with LVEF less than 40% Pulmonary: * No chronic obstructive pulmonary disease or other chronic pulmonary disease with pulmonary function test less than 50% of predicted Other: * No active infections * Not pregnant or nursing * Negative pregnancy test * Weight greater than 30 kg PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy for disease and recovered Chemotherapy: * At least 4 weeks since prior chemotherapy for disease and recovered * No prior intrahepatic artery infusion therapy with floxuridine Endocrine therapy: * Not specified Radiotherapy: * At least 4 weeks since prior radiotherapy for disease and recovered Surgery: * Not specified Other: * No concurrent immunosuppressive drugs * No concurrent chronic anticoagulants
References
Publications (0)
Data not yet available