Evidence map›Paper›PMID 41647286›Full record

ArticleESMO gastrointestinal oncology2023

Phase III trial of short-course radiotherapy followed by CAPOXIRI versus CAPOX in locally advanced rectal cancer: the ENSEMBLE trial.

J Watanabe, Y Kagawa, K Chida, K Ando, D Kotani, K Oba, H Bando, H Hojo, S Shimamoto, S Sakashita and 14 more

Registry-linked trialAbstract read
In one paragraph

Article in ESMO gastrointestinal oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05646511 (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), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05646511 phase3recruitingnot on this map

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

TypeinterventionalSponsorNational Cancer Center Hospital EastRan2022 to 2030Enrolled608ConditionsLocally Advanced Rectal CancerArmsSCRT, CAPOX, CAPOXIRI
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Total neoadjuvant therapy for rectal cancer: where are we now, where do we go?Clinical and translational radiation oncology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

J WatanabeDepartment of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama.
Y KagawaDepartment of Gastroenterological Surgery, Osaka General Medical Center, Osaka.
K ChidaDepartment of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama.
K AndoDepartment of Colorectal Surgery, National Cancer Center Hospital East, Chiba.
D KotaniDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba.
K ObaDepartment of Biostatistics, School of Public Health, The University of Tokyo, Tokyo.
H BandoTranslational Research Support Section, National Cancer Center Hospital East, Chiba.
H HojoDepartment of Radiation Oncology, National Cancer Center Hospital East, Chiba.
S ShimamotoDepartment of Radiology, Osaka General Medical Center, Osaka.
S SakashitaDivision of Pathology, National Cancer Center Hospital East, Chiba.
T KuwataDepartment of Pathology and Clinical Laboratories, National Cancer Center Hospital East, Chiba.
T TsuboyamaDepartment of Diagnostic and Interventional Radiology, Osaka University Graduate School of Medicine, Osaka.
N HosomiDepartment of Diagnostic Radiology, Osaka General Medical Center, Osaka.
M UemuraDepartment of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka.
K UeharaDepartment of Gastroenterological Surgery, Nippon Medical School Hospital, Tokyo.
M ItoDepartment of Colorectal Surgery, National Cancer Center Hospital East, Chiba.
E OkiDepartment of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka.
I TakemasaDepartment of Surgery, Surgical Oncology and Science, Sapporo Medical University, Sapporo.
E MisugiYCU Center for Novel and Exploratory Clinical Trials, Yokohama City University Hospital, Yokohama, Japan.
G SledgeCaris MPI, Inc. d/b/a/ Caris Life Sciences, Irving, USA.
K SumaniDepartment of Laboratory Medicine, National Cancer Center Hospital, Tokyo.
S ImotoDivision of Health Medical Intelligence, Human Genome Center, The Institute of Medical Science, The University of Tokyo, Tokyo.
T KatoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
T YoshinoDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The two key concerns in treating locally advanced rectal cancer (LARC) are as follows: (i) prolonging survival by reducing distant metastases and (ii) maintaining anorectal function and quality of life in surviving patients by safely avoiding rectal resection. To resolve these issues, in recent years, total neoadjuvant therapy (TNT), a preoperative combination of chemoradiotherapy or short-course radiotherapy (SCRT) and systemic chemotherapy, has been developed as a multidisciplinary treatment of LARC. There have been no prospective studies on consolidation triplet versus doublet regimens after SCRT. This randomized phase III trial (the ENSEMBLE trial) aims to test the superiority of consolidation irinotecan, capecitabine, and oxaliplatin over capecitabine and oxaliplatin after SCRT as TNT for LARC. The primary endpoint will be organ preservation-adapted disease-free survival in the intention-to-treat population. Moreover, no predictive biomarkers have been established for LARC. Therefore, to explore the predictive biomarkers for estimating the response to TNT and non-operative management, we planned translational research using multi-omics data, including genomic profiling with whole-genome/transcriptome sequencing of tissue and blood samples, liquid biopsy, radiomics, digital pathology, clinical features by deep learning with artificial intelligence.

Indexed as

locally advanced rectal cancernon-operative managementrandomized controlled trialtotal neoadjuvant therapytripletwhole-genome sequencing

Identifiers

PMID41647286
PMCPMC12836718

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.