Evidence map›Paper›PMID 40100473›Full record

ArticleInternational journal of colorectal disease2025

No operation after short-course radiotherapy followed by consolidation chemotherapy in locally advanced rectal cancer (NOAHS-ARC): study protocol for a prospective, phase II trial.

Felipe F Quezada-Díaz, Aron Bercz, Jose L Escobar, Nicole Caire, Lucia E Díaz-Feldman, Erik Manriquez, Gonzalo Carvajal

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in International journal of colorectal disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04864067 (No Operation After Short Course Equivalent Dose), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04864067 phase2completednot on this map

No Operation After Short Course Equivalent Dose (Ht) Radiation Therapy Followed By Consolidation Chemotherapy In Locally Advanced Rectal Cancer: The Prospective, Single Arm NOAHS-ARC Trial

TypeinterventionalSponsorServicio de Salud Metropolitano Sur OrienteRan2021 to 2026Enrolled39ConditionsRectal CancerArmsOxaliplatin, 5-Fluoracil, Leucovorin, Capecitabine, 5x5 Gy
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
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

7 authors.

Felipe F Quezada-DíazComplejo Asistencial Doctor Sotero del Rio, Avenida Concha y Toro #3459, 8150215, Puente Alto, Chile. ffquezad@gmail.com.
Aron BerczDepartment of Surgery, Colorectal Surgery Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Jose L EscobarEscuela de Medicina. Pontificia Universidad Católica de Chile, Santiago, Chile.
Nicole CaireComplejo Asistencial Doctor Sotero del Rio, Avenida Concha y Toro #3459, 8150215, Puente Alto, Chile.
Lucia E Díaz-FeldmanComplejo Asistencial Doctor Sotero del Rio, Avenida Concha y Toro #3459, 8150215, Puente Alto, Chile.
Erik ManriquezComplejo Asistencial Doctor Sotero del Rio, Avenida Concha y Toro #3459, 8150215, Puente Alto, Chile.
Gonzalo CarvajalComplejo Asistencial Doctor Sotero del Rio, Avenida Concha y Toro #3459, 8150215, Puente Alto, Chile.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeOrgan preservation through a watch-and-wait (W&W) strategy has become a viable option for select rectal cancer patients with clinical complete responses (cCR) to total neoadjuvant therapy (TNT). This approach limits the morbidity associated with multimodal treatment. However, the optimal treatment strategy and predictors of treatment response are still unresolved. Rectal cancer incidence is rising, particularly in developing countries, and the disease is a major public health concern in Chile. Prior to the no operation after short-course radiotherapy followed by consolidation chemotherapy in locally advanced rectal cancer (NOAHS-ARC) trial, TNT-based treatments and W&W programs had not been implemented in Chile. METHODS/

designThis single-arm, multicenter, phase II prospective trial, conducted in Santiago, Chile, will enroll patients with stage II/III rectal adenocarcinoma. Treatment involves induction short-course radiotherapy (25 Gy in 5 fractions) followed by consolidation chemotherapy (FOLFOX × 9 or CAPOX × 6 cycles). The response will be assessed 4-8 weeks after chemotherapy completion. Patients achieving cCR will be offered W&W, while those with incomplete responses will undergo total mesorectal excision. The primary endpoint is the rate of complete tumor response, combining pathologic complete responses (pCR) and sustained cCR (> 1 year), compared to a matched cohort treated with neoadjuvant chemoradiation alone. The trial aims to recruit 48 patients, assuming a combined pCR/sustained cCR rate of 12%. Quality of life measures will be assessed, and a biorepository of tissue and plasma samples will be established for future research, alongside serial endoscopic and MRI images. DISCUSSION: NOAHS-ARC seeks to advance organ preservation strategies in rectal cancer while pioneering TNT and W&W protocols in Chile. The study will also focus on functional outcomes and provide valuable data for improving patient care both locally and globally.

trial registrationClinicalTrials.gov identifier NCT04864067. Registered on April 28, 2021.

Indexed as

Consolidation ChemotherapyRectal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsClinical Trials, Phase II as TopicHumansNeoadjuvant TherapyNeoplasm StagingProspective StudiesTreatment OutcomeNonoperative managementOrgan preservationShort-course radiotherapyTotal neoadjuvant therapyWatch-and-wait

Identifiers

PMID40100473
PMCPMC11919929

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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.