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Spots Global Cancer Trial Database for Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

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Trial Identification

Brief Title: Trial of Nivolumab With FOLFOX After Chemoradiation in Rectal Cancer Patients

Official Title: Phase II Trial to Evaluate the Addition of Nivolumab to Neoadjuvant Chemoradiation With FOLFOX for Locally Advanced Rectal Cancer

Study ID: NCT03921684

Conditions

Rectal Cancer

Study Description

Brief Summary: This is a phase II, prospective, open label, one-center study for evaluation of the addition of nivolumab to the chemotherapy phase of the neoadjuvant treatment for locally advanced rectal cancer patients. Subjects must have received no prior treatment for rectal cancer (chemotherapy, radiotherapy or surgery) and no prior treatment with checkpoint inhibitors. Eligible subjects will receive chemoradiation for a period of 5 weeks, 6 cycles of chemo-immunotherapy (mFOLFOX6 + nivolumab) for a period of 12 weeks, once every 2 weeks, and will undergo surgery after 4 weeks.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Rabin Medical Center, Beilinson Hospital, Petach Tikva, , Israel

Contact Details

Name: Baruch Brenner, Prof

Affiliation: Rabin Medical Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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