Sequential Versus Combination Chemotherapy in Advanced Colorectal Carcinoma

Sponsor
Dutch Colorectal Cancer Group
Study ID
NCT00312000
Phase
PHASE3
Status
Completed

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • capecitabine-irinotecan — DRUG
    1. st line capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 2. nd line q 3 w irinotecan 350 mg/m2 IV infusion on day 1
  • capecitabine+irinotecan (1st line) — DRUG
    q 3 w irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 2 hours after discontinuation of the infusion followed by capecitabine 1000 mg/m2 orally b.i.d. on day 1-14

Study Details

Primary objective:To assess the efficacy, defined as overall survival, of sequential versus combination chemotherapy for advanced colorectal cancer (CRC). Methodology Open, randomised multicenter phase III study. Randomisation by centre will be centralized. 820 patiënts with histologically proven advanced CRC; not amenable to curative surgery. Measurable or evaluable disease. Age 18 years and above. WHO performance status 0-2. Test products: Arm A: First line: capecitabine capecitabine 1250 mg/m2 orally b.i.d. on day 1-14 (q3),until progression or unacceptable toxicity. Second line: irinotecan 350 mg/m2 IV infusion on day 1 (q3),until progression or unacceptable toxicity. Third line: oxaliplatin 130 mg/m2 IV infusion on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3). Arm B: First line: irinotecan 250 mg/m2 IV infusion in 30 minutes on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Second line: oxaliplatin 130 mg/m2 IV on day 1 and capecitabine 1000 mg/m2 orally b.i.d. on day 1-14 (q3), until progression or unacceptable toxicity. Patients will be followed by CT-scan every 9 weeks for response while on treatment, or at any other moment when progression is suspected. After cessation of chemotherapy, patients will be followed every 3 months until death. Clinical and laboratory toxicity/symptomatology will be graded according to NCI common criteria.

Key Dates

Start date
Jan 31, 2003
Status verified
Sep 2008
Primary completion
Feb 28, 2006
Completion
Dec 31, 2006

Study Design

Enrollment
820 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1Capecitabine-irinotecan
    1st line- 2nd line (3rd line oxaliplatin plus capecitabine)
  • Experimental: 2capecitabine plus irinotecan
    1st line (2nd line oxaliplatin plus capecitabine)

Primary Outcome Measure

Overall survival [ Time Frame: study duration ]

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