Evidence map›Paper›PMID 27194176›Full record

Trial reportBMC cancer2016

Preoperative chemoradiation with paclitaxel-carboplatin or with fluorouracil-oxaliplatin-folinic acid (FOLFOX) for resectable esophageal and junctional cancer: the PROTECT-1402, randomized phase 2 trial.

Mathieu Messager, Xavier Mirabel, Emmanuelle Tresch, Amaury Paumier, Véronique Vendrely, Laetitia Dahan, Olivier Glehen, Frederique Vasseur, Thomas Lacornerie, Guillaume Piessen and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02359968 (PReoperative Chemoradiation With Paclitaxel-carboplatin or With Fluorouracil-oxaliplatine-acide Folinique), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
5.6field-weighted citation impact, top 4% 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.

NCT02359968 phase2completednot on this map

PReoperative Chemoradiation With Paclitaxel-carboplatin or With Fluorouracil-oxaliplatine-acide Folinique (FOLFOX) for Resectable Esophageal and Junctional Cancer - A Randomized Phase II Trial

TypeinterventionalSponsorCentre Oscar LambretRan2015 to 2024Enrolled106ConditionsEsophageal Neoplasms, Gastro-esophageal Junction CancerArmsFOLFOX, CarboP-pacliT
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 40 citations in OpenAlex.

  1. Evaluation of tumor regression by neoadjuvant chemotherapy regimens for esophageal adenocarcinoma: a systematic review and meta-analysis.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2023
    Pooled it
  2. Review
  3. Article
  4. Neoadjuvant and adjuvant therapy in esophageal cancer.Journal of gastrointestinal oncology · 2023
    Review
  5. Review
  6. Review
  7. Review
  8. Review
  9. Evolving treatment paradigms in esophageal cancer.Annals of translational medicine · 2021
    Review
  10. Review
  11. Review
  12. Current status of esophageal cancer treatment.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2020
    Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Psychological support of esophageal cancer patient?Journal of thoracic disease · 2019
    Review
  20. 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

16 authors at 7 institutions in 2 countries.

Mathieu MessagerDepartment of Digestive and Oncological Surgery, University Hospital, Lille, France.
Xavier MirabelDepartment of Radiotherapy, Centre Oscar Lambret, Lille, France.
Emmanuelle TreschMethodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.
Amaury PaumierDepartment of Radiotherapy, Institut de Cancérologie de l'Ouest, Angers, France.
Véronique VendrelyFRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.
Laetitia DahanFRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.
Olivier GlehenFRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.
Frederique VasseurDepartment of Radiotherapy, Centre Oscar Lambret, Lille, France.
Thomas LacornerieUnit of Medical Physics, Centre Oscar Lambret, Lille, France.
Guillaume PiessenDepartment of Digestive and Oncological Surgery, University Hospital, Lille, France.
Farid El HajbiDepartment of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France.
William B RobbDepartment of Surgery, Beaumont Hospital, Dublin, Ireland.
Stéphanie ClisantClinical Research 18 Unit, Centre Oscar Lambret, Lille, France.
Andrew KramarMethodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.
Christophe MarietteDepartment of Digestive and Oncological Surgery, University Hospital, Lille, France.
Antoine AdenisFRench EsoGastric Tumours (FREGAT) Working Group, Lille, France. a-adenis@o-lambret.fr.
Centre Oscar Lambret · FROnco Lille · FRUniversité de Lille · FRAssistance Publique Hôpitaux de Marseille · FRBeaumont Hospital · IECentre de Recherche en Cancérologie de Lyon · FRInstitut de Cancérologie de l'Ouest · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOften curative treatment for locally advanced resectable esophageal or gastro-esophageal junctional cancer consists of concurrent neoadjuvant radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy regimens in this setting is a combination of a fluoropyrimidin and of a platinum analogue. Due to the promising results of the recent CROSS trial, another regimen combining paclitaxel and carboplatin is also widely used by European and American centers. No clinical study has shown the superiority of one treatment over the other. The objective of this Phase II study is to clarify clinical practice by comparing these two chemotherapy treatments. Our aim is to evaluate, in operable esophageal and gastro-esophageal junctional cancer, the complete resection rate and severe postoperative morbidity rate associated with these two neoadjuvant chemotherapeutic regimens (carboplatin-paclitaxel or fluorouracil-oxaliplatin-folinic acid) when each is combined with the radiation regime utilized in the CROSS trial. METHODS/

designPROTECT is a prospective, randomized, multicenter, open arms, phase II trial. Eligible patients will have a histologically confirmed adenocarcinoma or squamous cell carcinoma and be treated with neoadjuvant radiochemotherapy followed by surgery for stage IIB or stage III resectable esophageal cancer. A total of 106 patients will be randomized to receive either 3 cycles of FOLFOX combined to concurrent radiotherapy (41.4 Grays) or carboplatin and paclitaxel with the same radiation regimen, using a 1:1 allocation ratio. DISCUSSION: This ongoing trial offers the unique opportunity to compare two standards of chemotherapy delivered with a common regimen of preoperative radiation, in the setting of operable locally advanced esophageal or gastro-esophageal junctional tumors.

trial registrationNCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014).

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellChemoradiotherapyCisplatinDose Fractionation, RadiationEsophageal NeoplasmsFemaleFluorouracilHumansLeucovorinMaleMiddle AgedNeoadjuvant TherapyOrganoplatinum CompoundsCisplatinFluorouracilLeucovorinOrganoplatinum CompoundsPaclitaxelChemoradiotherapyEsophageal cancerFOLFOXPaclitaxel-carboplatinRandomized trial

Identifiers

PMID27194176
PMCPMC4872363
OpenAlexW2407837389

What OpenQuestion holds

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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.