Evidence map›Paper›PMID 25886378›Full record

Trial reportBMC cancer2015

A randomized phase II study of capecitabine-based chemoradiation with or without bevacizumab in resectable locally advanced rectal cancer: clinical and biological features.

Ramon Salazar, Jaume Capdevila, Berta Laquente, Jose Luis Manzano, Carles Pericay, Mercedes Martínez Villacampa, Carlos López, Ferran Losa, Maria Jose Safont, Auxiliadora Gómez and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01043484 (Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer), which is not on this map. Cited by 19 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 5 pooled it
3.2field-weighted citation impact, top 7% 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.

NCT01043484 phase2completednot on this map

Phase II Randomized Study to Compare Capecitabine + Bevacizumab Concomitantly With Radiotherapy Versus Capecitabine Concomitantly With Radiotherapy, as Neoadjuvant Treatment for Patients With Localized and Resectable Rectal Cancer

TypeinterventionalSponsorSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)Ran2009 to 2016Enrolled90ConditionsRectal CancerArmsBevacizumab + Capecitabine + Radiotherapy, Capecitabine + Radiotherapy
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 5 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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  16. Review
  17. Organ preservation in rectal cancer - Challenges and future strategies.Clinical and translational radiation oncology · 2017
    Review
  18. Article
  19. Recent advances in multidisciplinary approach for rectal cancer.International journal of clinical oncology · 2015
    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

18 authors at 16 institutions in 1 country.

Ramon SalazarCatalan Institute of Oncology (ICO), Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain. ramonsalazar@iconcologia.net.
Jaume CapdevilaMedical Oncology, Hospital Universitari Vall D'Hebrón, Barcelona, Spain. jacapdevila@vhebron.net.
Berta LaquenteCatalan Institute of Oncology (ICO), Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain. blaquente@iconcologia.net.
Jose Luis ManzanoMedical Oncology, Hospital Universitari German Trias I Pujol, Barcelona, Spain. jmanzano@iconcologia.net.
Carles PericayMedical Oncology, Complejo Sanitario Parc Taulí, Barcelona, Spain. cpericay@gmail.com.
Mercedes Martínez VillacampaCatalan Institute of Oncology (ICO), Bellvitge Biomedical Research Institute (IDIBELL), L'Hospitalet de Llobregat, Barcelona, Spain. mmvillacampa@iconcologia.net.
Carlos LópezMedical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain. clopez@humv.es.
Ferran LosaMedical Oncology, Hospital General de L'Hospitalet, Barcelona, Spain. ferran.losa@sanitatintegral.org.
Maria Jose SafontMedical Oncology, Hospital General Universitario de Valencia, Valencia, Spain. mjsafont@yahoo.es.
Auxiliadora GómezMedical Oncology, Reina Sofía Hospital, University of Córdoba, Maimonides Institute of Biomedical Research (IMIBIC); Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, Córdoba, Spain. magespanya@hotmail.com.
Vicente AlonsoMedical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain. valonsoo@salud.aragon.es.
Pilar EscuderoMedical Oncology, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. pilaresc@gmail.com.
Javier GallegoMedical Oncology, Hospital General U. de Elche, Alicante, Spain. j.gallegoplazas@gmail.com.
Javier SastreMedical Oncology, Hospital Clínico Universitario San Carlos, Madrid, Spain. jsastrev@salud.madrid.org.
Cristina GrávalosMedical Oncology, Hospital Doce de Octubre, Madrid, Spain. cgravalos@telefonica.net.
Sebastiano BiondoGeneral and Digestive Surgery Hospital Universitario de Bellvitge, Barcelona, Spain. sbiondo@bellvitgehospital.cat.
Amalia PalaciosRadiation Oncology, Hospital Universitario Reina Sofía, Córdoba, Spain. amalia.palacios.sspa@juntadeandalucia.es.
Enrique ArandaMedical Oncology, Reina Sofía Hospital, University of Córdoba, Maimonides Institute of Biomedical Research (IMIBIC); Spanish Cancer Network (RTICC), Instituto de Salud Carlos III, Córdoba, Spain. earandaa@seom.org.
Institut Català d'Oncologia · ESBellvitge University Hospital · ESCorporació Sanitària Parc Taulí · ESHospital Clínico San Carlos · ESHospital Clínico Universitario Lozano Blesa · ESHospital General de Catalunya · ESHospital General Universitario de Elche · ESHospital General Universitario De Valencia · ESHospital Universitari Germans Trias i Pujol · ESHospital Universitario 12 De Octubre · ESHospital Universitario Miguel Servet · ESHospital Universitario Reina Sofía · ESInstituto de Salud Carlos III · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESMarqués de Valdecilla University Hospital · ESVall d'Hebron Hospital Universitari · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPerioperatory chemoradiotherapy (CRT) improves local control and survival in patients with locally advanced rectal cancer (LARC). The objective of the current study was to evaluate the addition of bevacizumab (BEV) to preoperative capecitabine (CAP)-based CRT in LARC, and to explore biomarkers for downstaging.

methodsPatients (pts) were randomized to receive 5 weeks of radiotherapy 45 Gy/25 fractions with concurrent CAP 825 mg/m(2) twice daily 5 days per week and BEV 5 mg/kg once every 2 weeks (3 doses) (arm A), or the same schedule without BEV (arm B). The primary end point was pathologic complete response (ypCR: ypT0N0).

resultsNinety pts were included in arm A (44) or arm B (46). Grade 3-4 treatment-related toxicity rates were 16% and 13%, respectively. All patients but one (arm A) proceeded to surgery. The ypCR rate was 16% in arm A and 11% in arm B (p =0.54). Fifty-nine percent vs 39% of pts achieved T-downstaging (arm A vs arm B; p =0.04). Serial samples for biomarker analyses were obtained for 50 out of 90 randomized pts (arm A/B: 22/28). Plasma angiopoietin-2 (Ang-2) levels decreased in arm A and increased in arm B (p <0.05 at all time points). Decrease in Ang-2 levels from baseline to day 57 was significantly associated with tumor downstaging (p =0.02).

conclusionsThe addition of BEV to CAP-based preoperative CRT has shown to be feasible in LARC. The association between decreasing Ang-2 levels and tumor downstaging should be further validated in customized studies. TRIAL REGISTRY: Clinicaltrials.gov identifier NCT01043484. Trial registration date: 12/30/2009.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBiomarkers, TumorCapecitabineChemoradiotherapy, AdjuvantDrug Administration ScheduleFemaleHumansMaleMiddle AgedPatient CompliancePreoperative PeriodRadiotherapy DosageRectal NeoplasmsBevacizumabBiomarkers, TumorCapecitabine

Identifiers

PMID25886378
PMCPMC4343271
OpenAlexW1963729161

What OpenQuestion holds

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LicenceCC BY
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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.