Surgery Plus Chemo Versus Chemoradiotherapy Followed by Surgery Plus Chemo for Locally Recurrent Rectal Cancer

Recruiting Phase 3 Interventional Study
Rectal Cancer Recurrent
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
20 – 80
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
National Cancer Center Hospital East · Other
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About This Trial

JCOG1801 is a randomized phase III trial which was initiated in Japan in August 2019 to confirm the superiority of preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for local relapse-free survival over standard treatment, i.e. surgery plus adjuvant chemotherapy, for previously non-irradiated locally recurrent rectal cancer.

Trial Locations

Sorted by distance from Kentucky

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Eligibility Criteria
Inclusion Criteria: 1. Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer. 2. The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal ca…
Contacts

Yuichiro Tsukada, MD,PhD

+80-4-7133-1111

yutsukad@east.ncc.go.jp

CONTACT

Masaaki Ito, MD, PhD

+80-4-7133-1111

maito@east.ncc.go.jp

CONTACT