CompletedPhase 2

A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer

France91 participantsStarted 2007-10-23

Plain-language summary

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * histologically confirmed locally advanced rectal cancer; * measurable disease; * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Exclusion Criteria: * prior treatment with bevacizumab; * 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 central nervous system (CNS) disease; * clinically significant cardiovascular disease; * chronic treatment with high dose aspirin (more than \[\>\] 325 milligrams per day \[mg/day\]) or non-steroidal anti-inflammatory drugs.

What they're measuring

Percentage of Participants With Tumor Sterilization Defined by ypT0-N0

Timeframe: After surgery (Arm A: approximately 28-31 weeks after initiation of treatment; Arm B: approximately 13-15 weeks after initiation of treatment)

Trial details

NCT IDNCT00865189

SponsorHoffmann-La Roche

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03-23

Results submitted2017-04-13

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