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Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study

Phase 3
18 Years
80 Years
Open (Enrolling)
Colorectal Cancer, Metastatic Cancer

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Trial Information

Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study


- Compare the progression-free and overall survival of patients with resectable
colorectal liver metastases treated with surgery with or without neoadjuvant and
adjuvant oxaliplatin, fluorouracil, and leucovorin calcium.

- Compare the percentage of patients with total resection with these two treatments.

OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, prior adjuvant chemotherapy (yes vs no), plasma CEA level in ng/mL at diagnosis of
liver metastases (5 or less vs 6 to 30 vs 31 or greater), serosa extension of primary cancer
(absent T1 or T2 vs present T3 or T4), lymphatic spread of primary cancer (absent vs present
N+), time interval between diagnosis of primary tumor to metastases (2 years or more vs
fewer than 2 years), and number of metastases (1 to 3 vs 4). Patients are randomized to one
of two treatment arms.

- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium
(LV) IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
Treatment repeats every 15 days for 6 courses in the absence of disease progression or
unacceptable toxicity.

At 2 to 5 weeks after chemotherapy, patients undergo liver resection. Patients with
progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks
after completion of course 3 and do not receive postoperative chemotherapy.

At 2 to 5 weeks after surgery, patients receive oxaliplatin, LV, and 5-FU as in preoperative

- Arm II: Patients undergo liver resection. Patients are followed every 3 months for 2
years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study
within 3 years.

Inclusion Criteria


- 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



- 18 to 80

Performance status:

- WHO 0-2

- Karnofsky 60-100%

Life expectancy:

- Not specified


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

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


- No hepatic insufficiency


- Creatinine less than 2 times upper limit of normal


- No uncontrolled congestive heart failure or angina pectoris

- No hypertension or arrhythmia


- 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


Biologic therapy:

- No concurrent biologic therapy


- 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


- No concurrent radiotherapy


- See Disease Characteristics


- At least 30 days since prior investigational drugs

- No concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Bernard Nordlinger, MD

Investigator Affiliation:

Hopital Ambroise Pare


United States: Federal Government

Study ID:




Start Date:

September 2000

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Neoplasms