title: 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.
abstract: Often 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.
  
  
  
  PROTECT 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.
  
  
  
  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.
  
  
  
  NCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014).
authors.affiliation: Department of Digestive and Oncological Surgery, University Hospital, Lille, France.|University of Lille 2, Lille, France.|FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Messager
authors.affiliation: Department of Radiotherapy, Centre Oscar Lambret, Lille, France.|Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France.
authors.forename: Xavier
authors.initials: X
authors.lastname: Mirabel
authors.affiliation: Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Tresch
authors.affiliation: Department of Radiotherapy, Institut de Cancérologie de l'Ouest, Angers, France.
authors.forename: Amaury
authors.initials: A
authors.lastname: Paumier
authors.affiliation: FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.|Department of Radiotherapy, University Hospital, Bordeaux, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Vendrely
authors.affiliation: FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.|Department of Gastroenterology, University Hospital, Marseille, France.
authors.forename: Laetitia
authors.initials: L
authors.lastname: Dahan
authors.affiliation: FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.|Department of Digestive and Oncological Surgery, HCL Cancer Institute, Lyon, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Glehen
authors.affiliation: Department of Radiotherapy, Centre Oscar Lambret, Lille, France.
authors.forename: Frederique
authors.initials: F
authors.lastname: Vasseur
authors.affiliation: Unit of Medical Physics, Centre Oscar Lambret, Lille, France.
authors.forename: Thomas
authors.initials: T
authors.lastname: Lacornerie
authors.affiliation: Department of Digestive and Oncological Surgery, University Hospital, Lille, France.|University of Lille 2, Lille, France.|FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.|SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France.
authors.forename: Guillaume
authors.initials: G
authors.lastname: Piessen
authors.affiliation: Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France.
authors.forename: Farid
authors.initials: F
authors.lastname: El Hajbi
authors.affiliation: Department of Surgery, Beaumont Hospital, Dublin, Ireland.|the Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland.
authors.forename: William B
authors.initials: WB
authors.lastname: Robb
authors.affiliation: Clinical Research 18 Unit, Centre Oscar Lambret, Lille, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Clisant
authors.affiliation: Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.|SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France.
authors.forename: Andrew
authors.initials: A
authors.lastname: Kramar
authors.affiliation: Department of Digestive and Oncological Surgery, University Hospital, Lille, France.|University of Lille 2, Lille, France.|FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.|SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Mariette
authors.affiliation: FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France. a-adenis@o-lambret.fr.|SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France. a-adenis@o-lambret.fr.|Catholic University, Lille, France. a-adenis@o-lambret.fr.|Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France. a-adenis@o-lambret.fr.
authors.forename: Antoine
authors.initials: A
authors.lastname: Adenis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000627:therapeutic use; D019583:Dose Fractionation, Radiation; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009944:Organoplatinum Compounds; D017239:Paclitaxel; D002945:Cisplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: Chemoradiotherapy; Esophageal cancer; FOLFOX; Paclitaxel-carboplatin; Randomized trial