Xeloda and Bevacizumab to Treat Rectal Cancer

Sponsor
Institut Català d'Oncologia
Study ID
NCT00847119
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg.
  • capecitabine (Xeloda) — DRUG
    Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period
  • Rectal Radiotherapy — RADIATION
    Radiotherapy in rectum 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week.

Study Details

The project objective is to evaluate the efficacy of the neoadjuvant treatment with bevacizumab, capecitabine and radiotherapy, in patients with rectal adenocarcinoma resectable locally advanced (stage T3 or T4), with or without presence of ganglionar metastases and without distant metastases.

Key Dates

First listed
Feb 19, 2009
Start date
Sep 30, 2007
Status verified
Aug 2017
Primary completion
Jun 30, 2011
Completion
Feb 28, 2015

Study Design

Enrollment
43 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab & capecitabine & radiotheraphy
    Bevacizumab 4 cycles each 15 days, the first 10 mg/kg and the rest of cycles with 5 mg/kg. Radiotherapy 45 Gy starting on Bevacizumab 2nd cycle during 5 weeks, 1.8 Gy per day, 5 days at week. Capecitabine 900 mg/m2 two times a day concomitant during radiotherapy period.

Primary Outcome Measure

Pathologic complete response rate. % patients with pathologic complete response (absence of tumoral cells in the resected piece) [ Time Frame: Surgery date ]

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