NCT00002570

Immediate Compared With Delayed Chemotherapy in Advanced Colorectal Cancer Without Signs or Symptoms of Disease

A Phase III Study of Immediate Versus Delayed Chemotherapy for Asymptomatic Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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 may kill more tumor cells. It is not yet known which treatment regimen is more effective for colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease.

Detailed description

OBJECTIVES: I. Compare survival and quality of life in asymptomatic patients with advanced colorectal cancer randomized to immediate fluorouracil/leucovorin (5-FU/CF) vs. 5-FU/CF delayed until onset of symptoms. OUTLINE: Randomized, unblinded study. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Arm II: Observation followed by Single-Agent Chemotherapy with Drug Modulation. Clinical observation until symptomatic; followed by 5-FU; with CF. PROJECTED ACCRUAL: 144 patients will be entered over 4 years.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	fluorouracil	425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days
DRUG	leucovorin calcium	20 mg/m2 IV - number of cycles is determined by patient and physician

Timeline

• Start date: 1994-07-15
• Primary completion: 2000-11-01
• Completion: 2009-02-10
• First posted: 2004-08-31
• Last updated: 2020-04-06

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study