Evidence map›Paper›PMID 19269519›Full record

Trial reportLancet (London, England)2009

Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial.

David Sebag-Montefiore, Richard J Stephens, Robert Steele, John Monson, Robert Grieve, Subhash Khanna, Phil Quirke, Jean Couture, Catherine de Metz, Arthur Sun Myint and 4 more

13 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Lancet (London, England), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 13 registered trials, which are not on this map. Cited by 551 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
551citing papers in PubMed, 2 pooled it
–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.

NCT00003422 phase3completednot on this map

A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer

TypeinterventionalSponsorMedical Research CouncilRan1998 to 2010Enrolled1,800ConditionsColorectal CancerArmsfluorouracil, leucovorin calcium, adjuvant therapy, conventional surgery, neoadjuvant therapy
NCT01437514 phase2 / phase3terminatednot on this mapstarted 2011, after this paper: background citation

the Effect of the Preoperative Short-course Radiotherapy for the cT3/cN+ Mid-lower Rectal Cancer: a Prospective Randomized Study

TypeinterventionalSponsorWest China HospitalRan2011 to 2020Enrolled410ConditionsRectal NeoplasmsArmspreoperative short-course radiotherapy
NCT02498353 naunknown statusnot on this mapstarted 2015, after this paper: background citation

Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer

TypeinterventionalSponsorZhongnan HospitalRan2015 to 2020Enrolled100ConditionsRectal CancerArmspreoperative short-course radiotherapy with local boost, preoperative short-course radiotherapy without local boost, TME surgery
NCT02992886 phase2completednot on this mapstarted 2016, after this paper: background citation

Multicenter, Phase II Study of Preoperative Chemoradiotherapy With Raltitrexed for Intermediate or Locally Advanced Rectal Cancer in the Fit Elderly

TypeinterventionalSponsorChinese Academy of Medical SciencesRan2016 to 2021Enrolled68ConditionsRectal Neoplasms MalignantArmsPreoperative radiation, Raltitrexed, Pelvic surgery
NCT03001362 narecruitingnot on this mapstarted 2015, after this paper: background citation

Radical External Beam Chemoradiation in Patients With Rectal Cancer: a "Wait-and-see" Approach

TypeinterventionalSponsorMcGill University Health Centre/Research Institute of the McGill University Health CentreRan2015 to 2026Enrolled48ConditionsColorectal CarcinomaArmsRadical external beam radiotherapy
NCT03574493 completednot on this mapstarted 2018, after this paper: background citation

Rectal Surgery Evaluation Trial (RESET): Laparotomy vs Laparoscopy vs Robotic vs TaTME Rectal Surgery Matched Parallel Cohort Trial for High Surgical Risk Cancer Patients, With Mid- to Low Rectal Cancer

Typeobservational_patient_registrySponsorInstitut du Cancer de Montpellier - Val d'AurelleRan2018 to 2024Enrolled1,098ConditionsRectal CancerArmsTME with LAR
NCT04927897 recruitingnot on this mapstarted 2022, after this paper: background citation

DETECT: Defining the Target Volume for Endoluminal Radiation Boosting in Patients With Rectal Cancer

TypeobservationalSponsorMaastricht Radiation OncologyRan2022 to 2027Enrolled50ConditionsRectal CancerArmsUltrasound, Rectoscopy, Scan, e.g. CT (resection specimen)
NCT05338866 enrolling by invitationnot on this mapstarted 2022, after this paper: background citation

Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using Magnetic Resonance Guided Radiotherapy Linear Accelerator:A Prospective Phase 2 Trial

TypeobservationalSponsorSun Yat-sen UniversityRan2022 to 2033Enrolled58ConditionsRectal CancerArmsMagnetic resonance guided radiotherapy, Chemotherapy
NCT06991465 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

Organ Preservation in Rectal Adenocarcinoma Using Hypofractionated Pelvic Radiotherapy (Hypo-OPRA): A Phase II Clinical Trial

TypeinterventionalSponsorNeil KopekRan2023 to 2029Enrolled35ConditionsColorectal CarcinomaArmsRadiation Therapy, FOLFOX regimen, Capecitabine
NCT07194616 narecruitingnot on this mapstarted 2025, after this paper: background citation

Impact of Neoadjuvant Chemoradiotherapy Versus Surgery Alone on Circulating Tumor Cells in Patients With Stage II-III Rectal Cancer and Negative Circumferential Resection Margin: a Multicenter Randomized Clinical Trial

TypeinterventionalSponsorUniversity Hospital OstravaRan2025 to 2028Enrolled120ConditionsRectal Cancer PatientsArmsPrimary Surgery, Neoadjuvant radiochemotherapy and surgery
NCT07297004 phase2recruitingnot on this mapstarted 2025, after this paper: background citation

Stereotactic Body Radiation Therapy for Unresectable Locally Recurrent Rectal Cancer: A Prospective, Single-arm, Phase II Study

TypeinterventionalSponsorSixth Affiliated Hospital, Sun Yat-sen UniversityRan2025 to 2026Enrolled20ConditionsUnresectable Locally Recurrent Rectal CancerArmsStereotactic Body Radiation Therapy (SBRT)
NCT07372300 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

The Efficacy of Combination of Modulated Electro-Hyperthermia(mEHT) in The Multimodality Management in Locally Advanced Rectal Cancer: A Multicenter Phase 3 Randomized Control Trial.

TypeinterventionalSponsorShih-Kai HungRan2025 to 2027Enrolled126ConditionsLocally Advanced Rectal CarcinomaArmsHyperthermia
NCT07521605 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR/MSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol

TypeinterventionalSponsorGuangdong Provincial People's HospitalRan2026 to 2034Enrolled44ConditionsRectal Cancer PatientsArmsShort-Course Radiotherapy, Liposomal Irinotecan (nal-IRI), Capecitabine, Camrelizumab
3 · Its place in the literature

Who cites it

551 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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491 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors.

David Sebag-MontefioreSt James's University Hospital, Leeds, UK.
Richard J Stephens
Robert Steele
John Monson
Robert Grieve
Subhash Khanna
Phil Quirke
Jean Couture
Catherine de Metz
Arthur Sun Myint
Eric Bessell
Gareth Griffiths
Lindsay C Thompson
Mahesh Parmar

Funding

Medical Research Council MC_U122861325
6 · The paper itself

Abstract

backgroundPreoperative or postoperative radiotherapy reduces the risk of local recurrence in patients with operable rectal cancer. However, improvements in surgery and histopathological assessment mean that the role of radiotherapy needs to be reassessed. We compared short-course preoperative radiotherapy versus initial surgery with selective postoperative chemoradiotherapy.

methodsWe undertook a randomised trial in 80 centres in four countries. 1350 patients with operable adenocarcinoma of the rectum were randomly assigned, by a minimisation procedure, to short-course preoperative radiotherapy (25 Gy in five fractions; n=674) or to initial surgery with selective postoperative chemoradiotherapy (45 Gy in 25 fractions with concurrent 5-fluorouracil) restricted to patients with involvement of the circumferential resection margin (n=676). The primary outcome measure was local recurrence. Analysis was by intention to treat. This study is registered, number ISRCTN 28785842.

findingsAt the time of analysis, which included all participants, 330 patients had died (157 preoperative radiotherapy group vs 173 selective postoperative chemoradiotherapy), and median follow-up of surviving patients was 4 years. 99 patients had developed local recurrence (27 preoperative radiotherapy vs 72 selective postoperative chemoradiotherapy). We noted a reduction of 61% in the relative risk of local recurrence for patients receiving preoperative radiotherapy (hazard ratio [HR] 0.39, 95% CI 0.27-0.58, p<0.0001), and an absolute difference at 3 years of 6.2% (95% CI 5.3-7.1) (4.4% preoperative radiotherapy vs 10.6% selective postoperative chemoradiotherapy). We recorded a relative improvement in disease-free survival of 24% for patients receiving preoperative radiotherapy (HR 0.76, 95% CI 0.62-0.94, p=0.013), and an absolute difference at 3 years of 6.0% (95% CI 5.3-6.8) (77.5%vs 71.5%). Overall survival did not differ between the groups (HR 0.91, 95% CI 0.73-1.13, p=0.40).

interpretationTaken with results from other randomised trials, our findings provide convincing and consistent evidence that short-course preoperative radiotherapy is an effective treatment for patients with operable rectal cancer.

Indexed as

Postoperative CarePreoperative CareAdenocarcinomaAdultAgedAged, 80 and overChemotherapy, AdjuvantDisease-Free SurvivalFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalQuality of LifeRectal Neoplasms

Identifiers

PMID19269519
PMCPMC2668947

What OpenQuestion holds

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Registered trials

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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.