Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma

Sponsor
Dutch Colorectal Cancer Group
Study ID
NCT00442637
Phase
PHASE3
Status
Unknown

Conditions

  • Colorectal Cancer Metastatic

Eligibility Criteria

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

Interventions

  • capecitabine + bevacizumab — DRUG
    Ca 1250 mg/m2 daily orally continuously, B 7.5 mg/kg i.v. q 3 w
  • observation — OTHER
    observation after induction treatment

Study Details

The optimal duration of systemic treatment in patients with advanced colorectal cancer is unknown. In this study the effects of bevacizumab and low-dose continuous chemotherapy with capecitabine is investigated in patients who have responded to 6 courses of oxaliplatin, capecitabine and bevacizumab ("induction treatment", at standard doses). This treatment is continued until progression or severe toxicity. This regimen is compared to the effects a observation without treatment after the induction treatment. In case of disease progression, induction treatment will be reintroduced.

Key Dates

First listed
Mar 2, 2007
Start date
Jan 31, 2007
Status verified
Dec 2013
Primary completion
Sep 30, 2013
Completion
Dec 31, 2013

Study Design

Enrollment
635 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    observation
  • Active Comparator: 2
    capecitabine plus bevacizumab

Primary Outcome Measure

Progression-free survival after re-introduction of MTD chemotherapy and bevacizumab (PFS2) [ Time Frame: study duration ]

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