Spots Global Cancer Trial Database for Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29
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Trial Identification
Brief Title: Short-course Radiotherapy Followed by Consolidation Chemotherapy. 2021-001206-29
Official Title: Phase II Study of Short-course Radiotherapy Followed by Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: the ShorTrip Study
Study ID: NCT05253846
Conditions
Study Description
Brief Summary: The aim of the ShorTrip trail is to evaluate the activity and the safety of total neoadjuvant strategy with FOLFOXIRI as consolidation therapy preceded by short-course radiotherapy and followed by surgery in LARC patients.
Detailed Description: This is a prospective, open-label, multicentre, phase II single arm trial. Eligible patients with middle-high LARC will receive short-course radiotherapy followed by consolidation chemotherapy with FOLFOXIRI and surgery. The primary objective of this trial is to evaluate the rate of complete pathologic response (pCR)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
U.O. Oncologia Medica 2 Universitaria - Azienda Ospedaliero-Universitaria Pisana Dipartimento di Ricerca Traslazionale e Nuove Tecnologie - University of Pisa, Pisa, , Italy
Contact Details
Name: Roberto Moretto, MD
Affiliation: Azienda Ospedaliero, Universitaria Pisana
Role: PRINCIPAL_INVESTIGATOR
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