Evidence map›Paper›PMID 36254732›Full record

Trial reportBJS open2022

Effect of interval between neoadjuvant chemoradiotherapy and surgery on disease recurrence and survival in rectal cancer: long-term results of a randomized clinical trial.

Erhan Akgun, Cemil Caliskan, Osman Bozbiyik, Tayfun Yoldas, Basak Doganavsargil, Serdar Ozkok, Timur Kose, Bulent Karabulut, Nevra Elmas, Omer Ozutemiz

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BJS open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03287843 (Effect of Timing of Surgery After Neoadjuvant Chemoradiation on Histopathological Results, Complications, Recurrence and Survivals for Locally Advanced Rectal Cancer), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 23% of its field
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.

NCT03287843 nacompletednot on this map

Effect of Timing of Surgery After Neoadjuvant Chemoradiation on Histopathological Results, Complications, Recurrence and Survivals for Locally Advanced Rectal Cancer

TypeinterventionalSponsorEge UniversityRan2006 to 2022Enrolled350ConditionsNeoplasm, RectumArmsTotal mesorectal excision before 56 days (4-8 weeks), Total mesorectal excision after 56 days (8-12 weeks)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Article
  4. Article
  5. 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

10 authors at 1 institution in 1 country.

Erhan AkgunDepartment of General Surgery, Ege University School of Medicine, Izmir, Turkey.
Cemil CaliskanDepartment of General Surgery, Ege University School of Medicine, Izmir, Turkey.
Osman BozbiyikDepartment of General Surgery, Ege University School of Medicine, Izmir, Turkey.ORCID 0000-0002-1827-2720
Tayfun YoldasDepartment of General Surgery, Ege University School of Medicine, Izmir, Turkey.
Basak DoganavsargilDepartment of Pathology, Ege University School of Medicine, Izmir, Turkey.
Serdar OzkokDepartment of Radiation Oncology, Ege University School of Medicine, Izmir, Turkey.
Timur KoseDepartment of Biostatistics, Ege University School of Medicine, Izmir, Turkey.
Bulent KarabulutDepartment of Medical Oncology, Ege University School of Medicine, Izmir, Turkey.
Nevra ElmasDepartment of Radiology, Ege University School of Medicine, Izmir, Turkey.
Omer OzutemizDepartment of Gastroenterology, Ege University School of Medicine, Izmir, Turkey.
Ege University · TR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal timing of surgery following chemoradiotherapy (CRT) is controversial. This trial aimed to assess disease recurrence and survival rates between patients with locally advanced rectal adenocarcinoma (LARC) who underwent total mesorectal excision (TME) after a waiting interval of 8 weeks or less (classic interval; CI) versus more than 8 weeks (long interval; LI) following preoperative CRT.

methodsThis was a phase III, single-centre, randomized clinical trial. Patients with LARC situated within 12 cm of the anal verge (T3-T4 or N+ disease) were randomized to undergo TME within or after 8 weeks after CRT.

resultsBetween January 2006 and January 2017, 350 patients were randomized, 175 to each group. As of February 2022, the median follow-up time was 80 (6-174) months. Among the 322 included patients (CI, 159; LI, 163) the cumulative incidence of locoregional recurrence at 5 years was 10.1 per cent in the CI group and 6.9 per cent in the LI group (P = 0.143). The cumulative incidence of distant metastasis at 5 years was 30.8 per cent in the CI group and 18.6 per cent in the LI group (sub-HR = 1.78; 95 per cent c.i. 1.14 to 2.78, P = 0.010). The disease-free survival (DFS) in each group was 59.7 and 69.9 per cent respectively (P = 0.157), and overall survival (OS) rates at 5 years were 73.6 versus 77.9 per cent (P = 0.476).

conclusionIncidence of distant metastasis decreased with an interval between CRT and surgery exceeding 8 weeks, but this did not impact on DFS or OS. REGISTRATION NUMBER: NCT03287843 (http://www.clinicaltrials.gov).

Indexed as

Neoadjuvant TherapyRectal NeoplasmsChemoradiotherapyHumansNeoplasm Recurrence, LocalNeoplasm Staging

Identifiers

PMID36254732
PMCPMC9577542
OpenAlexW4306728879

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.