Spots Global Cancer Trial Database for Total Neoadjuvant Therapy of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer (ENSEMBLE)
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Trial Identification
Brief Title: Total Neoadjuvant Therapy of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer (ENSEMBLE)
Official Title: A Multicenter Randomized Phase III Study of Short-term Radiotherapy Plus CAPOX and Short-term Radiotherapy Plus CAPOXIRI as Preoperative Treatment for Locally Advanced Rectal Cancer
Study ID: NCT05646511
Conditions
Study Description
Brief Summary: This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.
Detailed Description: Total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC) has the promise, which means non-operative management (NOM) enable more patients (pts) with a complete clinical response (cCR) or near-complete clinical responses (nCR) after TNT to avoid subsequent radical surgery, with potentially maintaining anorectal function and quality of life (QoL). Recently, PRODIGE-23 trial demonstrated that triplet regimen (Irinotecan, oxaliplatin and fluoropyrimidine) before preoperative chemoradiotherapy (CRT) significantly improved outcomes compared with CRT. However, there has been no prospective study comparing consolidation triplet with doublet regimens following short course radiotherapy (SCRT). The aim of this randomized phase III trial is to test superiority of consolidation irinotecan, capecitabine and oxaliplatin (CAPOXIRI) vs. capecitabine and oxaliplatin (CAPOX) following SCRT as TNT in pts with LARC. Pts in both groups will be re-staged after completing TNT before radical surgery according to the Memorial Sloan Kettering Regression Schema; pts with incomplete response (iCR) will undergo total mesorectal excision (TME), cCR pts will receive NOM, and nCR pts will undergo TME or NOM by a physician discretion under the recommendation of blind assessment by the designated NOM central committee. Pts will be followed by CT, MRI, colonoscopy and liquid biopsy every 4 months for 2 years, and every 6 months thereafter up to 5 years. To detect a decrease in 3-year cumulative probability of organ preservation-adapted Disease free survival (DFS) from 75.0% to 81.7%, corresponding to a target hazard ratio of 0·70, a total of 608 pts (196 events) would achieve 70% power at a two-sided α significance level of 0.05.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cancer Center Hospital East, Chiba, , Japan
Kyushu University Hospital, Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center, Fukuoka, , Japan
Gifu University Hospital, Gifu, , Japan
Hirosaki University Hospital, Hirosaki, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
St. Marianna University Hospital, Kawasaki, , Japan
University of Occupational and Environmental Health Hospital, Kitakyushu, , Japan
Nagoya University Hospital, Nagoya, , Japan
Ohara Memorial Kurashiki Central Medical Organization Kurashiki Central Hospital, Okayama, , Japan
Kindai University Hospital, Osaka, , Japan
National Hospital Organization Osaka Medical Center, Osaka, , Japan
Osaka Prefectural Hospital Organization Osaka Acute and General Medical Center, Osaka, , Japan
Osaka University Hospital, Osaka, , Japan
Kitasato University Hospital, Sagamihara, , Japan
Sapporo Medical University Hospital, Sapporo, , Japan
Foundation for Cancer Research Ariake Hospital, Tokyo, , Japan
Keio University Hospital, Tokyo, , Japan
National Cancer Center Hospital, Tokyo, , Japan
Nippon Medical School Hospital, Tokyo, , Japan
Tokyo Metropolitan Hospital Organization Tokyo Metropolitan Komagome Hospital, Tokyo, , Japan
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center, Yokohama, , Japan
Yokohama City University Hospital, Yokohama, , Japan
Yokohama City University Medical Center, Yokohama, , Japan
Federation of National Public Service Personnel Mutual Aid Associations Yokosuka Mutual Aid Hospital, Yokosuka, , Japan
Contact Details
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