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A Randomized, Open-label Study to Assess the Effect on Tumor Response, and the Safety, of Two Neo-adjuvant Approaches With Avastin in Newly-diagnosed Patients With High Risk Locally-advanced Rectal Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer

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Trial Information

A Randomized, Open-label Study to Assess the Effect on Tumor Response, and the Safety, of Two Neo-adjuvant Approaches With Avastin in Newly-diagnosed Patients With High Risk Locally-advanced Rectal Cancer


Inclusion Criteria:



- adult patients, 18-75 years of age;

- histologically confirmed locally advanced rectal cancer;

- measurable disease;

- ECOG performance status 0-1;

- no prior chemotherapy or radiation therapy for rectal cancer.

Exclusion Criteria:

- prior treatment with Avastin;

- prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;

- previous history of malignancy (other than basal and squamous cell cancer of the
skin, or in situ cancer of the cervix);

- history or evidence of CNS disease;

- clinically significant cardiovascular disease;

- chronic treatment with high dose aspirin (>325mg/day) or NSAID.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of sterilisation of tumoral specimen: YpT0-N0

Outcome Time Frame:

After surgery (6-8 weeks after chemoradiation)

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

France:AFSSAPS

Study ID:

ML19202

NCT ID:

NCT00865189

Start Date:

October 2007

Completion Date:

March 2016

Related Keywords:

  • Colorectal Cancer
  • Rectal Neoplasms
  • Colorectal Neoplasms

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