Status:
UNKNOWN
Adaptive Individualized High-Dose Radiotherapy Analysis-REctum-1 (AIDA-RE-1)
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Conditions:
Rectal Cancer
Radiotherapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Aim of the study is to evaluate achievement of complete pathologic response (pCR) in high-risk rectal cancer treated with neoadjuvant concomitant chemotherapy plus adaptive-intensity modulated imaging...
Detailed Description
AIDA-RE-1 is an interventional prospective trial for the treatment of locally advanced high-risk rectal cancer. In neoadjuvant setting, patients are treated with standard chemotherapy plus experimenta...
Eligibility Criteria
Inclusion
- histologically confirmed diagnosis of locally advanced rectal cancer (cT3N+, cT4Nx, local relapse, cT3N0); cT2N+ is acceptable if low rectum is involved
- M0
- ECOG 0-2
Exclusion
- M1
- familial adenomatous polyposis (FAP), non-polyposis hereditary colorectal cancer, inflammatory bowel disease
- severe cardiopathy
- previous pelvic RT
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03479814
Start Date
August 1 2016
End Date
January 1 2019
Last Update
March 27 2018
Active Locations (1)
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1
Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital
Bologna, BO, Italy, 40138