Know Cancer

or
forgot password

A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Advanced Colorectal Cancer

Thank you

Trial Information

A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer


Inclusion Criteria:



- Patient is at least 18 years of age

- Good organ function

- Locally advanced (according to RECIST criteria) adenocarcinoma of the rectum

Exclusion Criteria:

- Evidence of distant metastases

- Contraindication for bevacizumab

- Pregnant or breastfeeding women.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic complete response (ypT0N0) rate

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Eric Van Cutsem, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

UZ Leuven

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

s51104 - ML5194

NCT ID:

NCT00828672

Start Date:

June 2009

Completion Date:

December 2016

Related Keywords:

  • Advanced Colorectal Cancer
  • assess activity
  • bevacizumab
  • capecitabine
  • radiation therapy
  • oxaliplatin
  • pre-operative treatment
  • TME (total mesorectal excision).
  • Colorectal Neoplasms

Name

Location