10779/rcsi.10801085.v1
Mathieu Messager
Mathieu
Messager
Xavier Mirabel
Xavier
Mirabel
Emmanuelle Tresch
Emmanuelle
Tresch
Amaury Paumier
Amaury
Paumier
Véronique Vendrely
Véronique
Vendrely
Laetitia Dahan
Laetitia
Dahan
Olivier Glehen
Olivier
Glehen
Frederique Vasseur
Frederique
Vasseur
Thomas Lacornerie
Thomas
Lacornerie
Guillaume Piessen
Guillaume
Piessen
Farid El Hajbi
Farid El
Hajbi
William B. Robb
William B.
Robb
Stéphanie Clisant
Stéphanie
Clisant
Andrew Kramar
Andrew
Kramar
Christophe Mariette
Christophe
Mariette
Antoine Adenis
Antoine
Adenis
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.
Royal College of Surgeons in Ireland
2019
Chemoradiotherapy
Esophageal cancer
FOLFOX
Paclitaxel-carboplatin
Randomized trial
Surgery
2019-11-22 17:32:37
Journal contribution
https://repository.rcsi.com/articles/journal_contribution/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_/10801085
<p>BACKGROUND: 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.</p>
<p>METHODS/DESIGN: 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.</p>
<p>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.</p>
<p>TRIAL REGISTRATION: NCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014).</p>