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Tytuł pozycji:

A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study).

Tytuł :
A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study).
Autorzy :
Kadota T; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Tsukada Y; Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Ito M; Department of Colorectal Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
Katayama H; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Mizusawa J; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Nakamura N; Department of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.
Ito Y; Department of Radiation Oncology, Showa University School of Medicine, Tokyo, Japan.
Bando H; Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Ando M; Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan.
Onaya H; Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.
Fukuda H; JCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Kanemitsu Y; Department of Colorectal Surgery, National Cancer Center Hospital, Tokyo, Japan.
Pokaż więcej
Źródło :
Japanese journal of clinical oncology [Jpn J Clin Oncol] 2020 Aug 04; Vol. 50 (8), pp. 953-957.
Typ publikacji :
Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial
Język :
English
Imprint Name(s) :
Publication: Oxford : Oxford University Press
Original Publication: Tokyo, Foundation of Clinical Oncology.
MeSH Terms :
Chemoradiotherapy*
Preoperative Care*
Neoplasm Recurrence, Local/*therapy
Rectal Neoplasms/*therapy
Adult ; Aged ; Female ; Follow-Up Studies ; Humans ; Japan ; Male ; Medical Oncology ; Middle Aged ; Neoplasm Recurrence, Local/pathology ; Neoplasm Staging ; Quality of Life ; Rectal Neoplasms/pathology ; Recurrence ; Treatment Outcome
Contributed Indexing :
Keywords: local relapse-free survival; locally recurrent rectal cancer; preoperative chemoradiotherapy; randomized controlled trial; surgery
Molecular Sequence :
ClinicalTrials.gov NCT04288999
Entry Date(s) :
Date Created: 20200516 Date Completed: 20200917 Latest Revision: 20200917
Update Code :
20201023
DOI :
10.1093/jjco/hyaa058
PMID :
32409830
Czasopismo naukowe
A randomized phase III trial was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy compared to the standard treatment, i.e. surgery plus adjuvant chemotherapy, for locally recurrent rectal cancer in local relapse-free survival. In all, 110 patients from 43 Japanese institutions will be recruited over a period of 6 years. Eligible patients would be registered and randomly assigned to each group with an allocation ratio of 1:1. The primary endpoint is local relapse-free survival. The secondary endpoints are overall survival, relapse-free survival, proportion of local relapse, proportion of distant relapse, proportion of patients with pathological R0 resection, response rate of preoperative chemoradiotherapy (preoperative chemoradiotherapy arm), pathological complete response rate (preoperative chemoradiotherapy arm), proportion of patients who completed the protocol treatment, incidence of adverse events (adverse reactions) and quality of life after surgery. This trial has been registered at the Japan Registry of Clinical Trial: jRCTs031190076 [https://jrct.niph.go.jp/latest-detail/jRCTs031190076] and ClinicalTrials.gov: NCT04288999 [https://clinicaltrials.gov/ct2/show/NCT04288999].
(© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.)

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