Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 combining chemotherapy with surgery may kill more tumor cells. It is not yet known if surgery is more effective with or without chemotherapy for liver metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have liver metastases from colorectal cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Collaborators: Arbeitsgruppe Lebermetastasen und Tumoren; Australasian Gastro-Intestinal Trials Group; Cancer Research UK; Fondation Francaise de Cancerologie Digestive
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of potentially resectable colorectal liver metastases that meets one of the following criteria:

• Metachronous metastases after complete resection of primary tumor without gross or microscopic evidence of residual disease

• Synchronous metastases after complete resection of primary tumor more than 1 month before study

• Synchronous metastases with sufficient evidence (i.e., CAT scan or diagnostic laparoscopy) that both the primary tumor and liver metastases can be completely resected during the same procedure and resection of primary may be delayed 3-4 months

PATIENT CHARACTERISTICS:

Age:

• 18 to 80

Performance status:

• WHO 0-2

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic:

• No hepatic insufficiency

Renal:

• Creatinine less than 2 times upper limit of normal

Cardiovascular:

• No uncontrolled congestive heart failure or angina pectoris

• No hypertension or arrhythmia

Other:

• No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer

• No peripheral neuropathy greater than grade 1

• No prior significant neurologic or psychiatric disorders

• No active infection

• Not pregnant or nursing

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent biologic therapy

Chemotherapy:

• No prior chemotherapy for advanced disease

• Prior adjuvant chemotherapy for primary cancer allowed unless included oxaliplatin

• No other concurrent chemotherapy

Endocrine therapy:

• No concurrent anticancer endocrine therapy

Radiotherapy:

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since prior investigational drugs

• No concurrent investigational drugs