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
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
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