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Maintenance Treatment Versus Observation After Induction in Advanced Colorectal Carcinoma

NCT00442637 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 635

Last updated 2013-12-12

No results posted yet for this study

Summary

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.

Conditions

  • Colorectal Cancer Metastatic

Interventions

DRUG

capecitabine + bevacizumab

Ca 1250 mg/m2 daily orally continuously, B 7.5 mg/kg i.v. q 3 w

OTHER

observation

observation after induction treatment

Sponsors & Collaborators

  • Koningin Wilhelmina Fonds

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Dutch Colorectal Cancer Group

    lead OTHER

Principal Investigators

  • C. JA Punt, MD PhD · Amsterdam Medical Centre, Amsterdam Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442637 on ClinicalTrials.gov