Randomized phase III trial of post-operative chemotherapy for patients with stage I/II/III small bowel adenocarcinoma (JCOG1502C, J-BALLAD)

A randomized phase III trial was initiated in May 2017 to confirm the superiority of post-operative therapy with capecitabine and oxaliplatin over observation in terms of relapse-free survival in patients with curatively resected small bowel adenocarcinoma. Total 150 patients will be enrolled from 2...

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Bibliographic Details
Published in:Japanese journal of clinical oncology 2019-03, Vol.49 (3), p.287-290
Main Authors: Kitahara, Hideaki, Honma, Yoshitaka, Ueno, Makoto, Kanemitsu, Yukihide, Ohkawa, Shinichi, Mizusawa, Junki, Furuse, Junji, Shimada, Yasuhiro
Format: Article
Language:English
Subjects:
Adenocarcinoma - drug therapy
Adenocarcinoma - mortality
Adenocarcinoma - surgery
Adolescent
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Capecitabine - therapeutic use
Chemotherapy, Adjuvant
Clinical Trials, Phase I as Topic
Clinical Trials, Phase III as Topic
Disease-Free Survival
Female
Humans
Ileal Neoplasms - drug therapy
Japan
Jejunal Neoplasms - drug therapy
Jejunal Neoplasms - mortality
Jejunal Neoplasms - surgery
Male
Middle Aged
Oxaliplatin - therapeutic use
Postoperative Period
Randomized Controlled Trials as Topic
Young Adult
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Summary:A randomized phase III trial was initiated in May 2017 to confirm the superiority of post-operative therapy with capecitabine and oxaliplatin over observation in terms of relapse-free survival in patients with curatively resected small bowel adenocarcinoma. Total 150 patients will be enrolled from 20 Japanese institutions over a period of 6.5 years. Relapse-free survival is the primary endpoint, while the secondary endpoints are overall survival, disease-free survival as defined by the Japan Clinical Oncology Group (JCOG), disease-free survival as defined by the International Rare Cancer Initiative (IRCI), and adverse events. Global phase III trial of IRCI to confirm the superiority of post-operative chemotherapy for small bowel adenocarcinoma was started in the UK in August 2015 (ClinicalTrials.gov Identifier: NCT02502370). An integrated analysis of the IRCI trial and our study are planned. Our trial has been registered in the UMIN Clinical Trials Registry as UMIN000027280 (http://www.umin.ac.jp/ctr/index.htm).
ISSN:1465-3621
1465-3621
DOI:10.1093/jjco/hyy188