Evidence map›Paper›PMID 27655166›Full record

ArticleTrials2016

Lapatinib-capecitabine versus capecitabine alone as radiosensitizers in RAS wild-type resectable rectal cancer, an adaptive randomized phase II trial (LaRRC trial): study protocol for a randomized controlled trial.

Nuno Sousa, Olga Sousa, Lúcio Lara Santos, Rui Henrique, Manuel R Teixeira, Mário Dinis-Ribeiro, Armando Teixeira-Pinto

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 33% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
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 at 4 institutions in 2 countries.

Nuno SousaMedical Oncology Department, IPO Porto FG, EPE, Rua António Bernardino de Almeida, 4200-072, Porto, Portugal. nuno.sousa@ipoporto.min-saude.pt.
Olga SousaRadioncology Department, IPO Porto FG, EPE, Rua António Bernardino de Almeida, 4200-072, Porto, Portugal.
Lúcio Lara SantosSurgical Oncology Department, IPO Porto FG, EPE, Rua António Bernardino de Almeida, 4200-072, Porto, Portugal.
Rui HenriqueDepartment of Pathology, IPO Porto FG, EPE, Rua António Bernardino de Almeida, 4200-072, Porto, Portugal.
Manuel R TeixeiraGenetics Department, IPO Porto FG, EPE, Rua António Bernardino de Almeida, 4200-072, Porto, Portugal.
Mário Dinis-RibeiroGastroenterology Department, IPO Porto FG, EPE, Rua António Bernardino de Almeida, 4200-072, Porto, Portugal.
Armando Teixeira-PintoScreening and Test Evaluation Program (STEP), Sydney School of Public Health, The University of Sydney, Sydney, NSW, 2006, Australia.
IPO Porto · PTCentre for Health Technology and Services Research · PTPolytechnic Institute of Porto · PTUniversity of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPreoperative radiochemotherapy followed by surgical removal of the rectum with total mesorectum excision is the preferred treatment option for stages II and III rectal cancer. However, development of metastatic disease is the main cause of death for these patients with 5-year disease-free survival rates of 56 %. Anti-epidermal growth factor receptor (EGFR) targeted therapy is effective in metastatic rectal cancer, and human epidermal growth factor receptor 2 (HER-2) signaling may mediate resistance to EGFR inhibitors. Moreover, preclinical data support a synergistic effect of EGFR inhibition with radiation therapy. METHODS/

designThis Bayesian phase II trial with adaptive randomization was designed to assess the efficacy of adding lapatinib, a dual inhibitor of EGFR and HER-2, to standard radiochemotherapy with capecitabine in stages II and III rectal cancer. DISCUSSION: The results of this trial will provide evidence of the feasibility and efficacy of the combination of lapatinib-capecitabine as radiosensitizers and explore potential predictive biomarkers for response to this novel neoadjuvant approach to resectable rectal cancer.

trial registrationEudraCT 2013-001203-36 . Registered on 13 December 2013.

Indexed as

Bayesian adaptive randomizationCapecitabine (capecitabine [supplementary concept])Clinical trialLapatinib (lapatinib [supplementary concept])Neoadjuvant therapyPhase IIRadiotherapyRandomized adaptive trialRectal neoplasms

Identifiers

PMID27655166
PMCPMC5031350
OpenAlexW2522924902

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.