Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients

Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT01554059
Phase
PHASE2
Status
Completed

Conditions

  • Rectal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 5mg/m2 D1,D15,D29,D43;
  • Oxaliplatin — DRUG
    Oxaliplatin 85mg/m2 D1,D57; Oxaliplatin 85mg/m2 biweekly \* 6 doses 3-4 weeks after radical resection
  • 5-FU — DRUG
    5-FU 2800mg/m2 civ 48 hours D1,D57; 5-FU 2800mg/m2 civ 48 hours biweekly\*6 doses 3-4 weeks after radical resection; 5-FU 200mg/m2/day civ D15-19,D22-26,D29-33,D36-40,D43-47;
  • Radiotherapy — RADIATION
    2GY daily \*20次

Study Details

The purpose of the study is to evaluate the efficacy and safety of the combination of cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy as neoadjuvant treatment for patients with locally advanced but resectable rectal adenocarcinoma.

Key Dates

First listed
Mar 14, 2012
Start date
Mar 31, 2012
Status verified
Nov 2014
Primary completion
May 31, 2013
Completion
Aug 31, 2014

Study Design

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

Primary Outcome Measure

Pathological complete response rate [ Time Frame: one year ]

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