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

BMC Cancer

Study Protocol

Stéphanie Clisant¹  Mathieu Messager²  Christophe Mariette³  Guillaume Piessen³  Farid El Hajbi⁴  Frederique Vasseur⁵  Xavier Mirabel⁶  Amaury Paumier⁷  William B. Robb⁸  Olivier Glehen⁹  Laetitia Dahan^1,10  Véronique Vendrely^1,11  Antoine Adenis^1,12  Emmanuelle Tresch^1,13  Andrew Kramar^1,14  Thomas Lacornerie^1,15 

[1] Clinical Research 18 Unit, Centre Oscar Lambret, Lille, France;Department of Digestive and Oncological Surgery, University Hospital, Lille, France;University of Lille 2, Lille, France;FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France;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;Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France;Department of Radiotherapy, Centre Oscar Lambret, Lille, France;Department of Radiotherapy, Centre Oscar Lambret, Lille, France;Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France;Department of Radiotherapy, Institut de Cancérologie de l’Ouest, Angers, France;Department of Surgery, Beaumont Hospital, Dublin, Ireland;the Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland;FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France;Department of Digestive and Oncological Surgery, HCL Cancer Institute, Lyon, France;FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France;Department of Gastroenterology, University Hospital, Marseille, France;FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France;Department of Radiotherapy, University Hospital, Bordeaux, France;FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France;SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France;Catholic University, Lille, France;Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France;Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France;Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France;SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France;Unit of Medical Physics, Centre Oscar Lambret, Lille, France;

关键词: Esophageal cancer;    FOLFOX;    Paclitaxel-carboplatin;    Chemoradiotherapy;    Randomized trial;   

DOI  :  10.1186/s12885-016-2335-9

 received in 2015-09-18, accepted in 2016-05-03,  发布年份 2016

来源: Springer

【 摘 要 】

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.DiscussionThis 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)

【 授权许可】

CC BY   
© Messager et al. 2016