Know Cancer

or
forgot password

A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES


Phase 3
N/A
N/A
Open (Enrolling)
Both
Colorectal Cancer, Metastatic Cancer

Thank you

Trial Information

A RANDOMISED TRIAL OF INTRAVENOUS VERSUS INTRAHEPATIC ARTERIAL 5-FU AND LEUCOVORIN FOR COLORECTAL LIVER METASTASES


OBJECTIVES: I. Compare the survival and response rates of patients with colorectal liver
metastases treated with intravenous vs. intrahepatic arterial infusion of
fluorouracil/leucovorin. II. Assess the effect of these 2 treatments on symptoms and quality
of life of these patients.

OUTLINE: Randomized study. Patients randomized to Arm II should have a preoperative hepatic
angiography; at laparotomy, an intrahepatic arterial catheter is fused into the
gastroduodenal artery to establish an infusion of both lobes of the liver. Arm I:
Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with
Leucovorin calcium, CF, NSC-3590. Intravenous infusion. Arm II: Single-Agent Chemotherapy
with Drug Modulation. 5-FU; with CF. Intrahepatic arterial infusion.

PROJECTED ACCRUAL: 312 patients are expected to be randomized within 3-4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum
with metastases confined to the liver and not amenable to surgery

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: More
than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 3.5 mg/dL (50
micromoles/liter) Renal: Not specified Cardiovascular: No uncontrolled heart disease
(e.g., congestive heart failure, angina) Other: No uncontrolled infection No other
uncontrolled medical illness

PRIOR CONCURRENT THERAPY: No prior fluorouracil (5-FU) for advanced disease More than 6
months since adjuvant 5-FU (e.g., in AXIS or QUASAR studies)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

David J. Kerr, MD, FRCP, DSc

Investigator Role:

Study Chair

Investigator Affiliation:

University Hospital Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000064434

NCT ID:

NCT00002692

Start Date:

December 1994

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • liver metastases
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location