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BMC Cancer. 2016 May 18;16:318. doi: 10.1186/s12885-016-2335-9.

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.

Author information

1
Department of Digestive and Oncological Surgery, University Hospital, Lille, France.
2
University of Lille 2, Lille, France.
3
FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France.
4
Department of Radiotherapy, Centre Oscar Lambret, Lille, France.
5
Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France.
6
Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.
7
Department of Radiotherapy, Institut de Cancérologie de l'Ouest, Angers, France.
8
Department of Radiotherapy, University Hospital, Bordeaux, France.
9
Department of Gastroenterology, University Hospital, Marseille, France.
10
Department of Digestive and Oncological Surgery, HCL Cancer Institute, Lyon, France.
11
Unit of Medical Physics, Centre Oscar Lambret, Lille, France.
12
SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France.
13
Department of Surgery, Beaumont Hospital, Dublin, Ireland.
14
the Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland.
15
Clinical Research 18 Unit, Centre Oscar Lambret, Lille, France.
16
FRench EsoGastric Tumours (FREGAT) Working Group, Lille, France. a-adenis@o-lambret.fr.
17
SIte de Recherche Intégrée sur le Cancer (SIRIC) OncoLille, Lille, France. a-adenis@o-lambret.fr.
18
Catholic University, Lille, France. a-adenis@o-lambret.fr.
19
Department of Gastrointestinal Oncology, Centre Oscar Lambret, Lille, France. a-adenis@o-lambret.fr.

Abstract

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.

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.

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 REGISTRATION:

NCT02359968 (ClinicalTrials.gov) (registration date: 9 FEB 2015), EudraCT: 2014-000649-62 (registration date: 10 FEB 2014).

KEYWORDS:

Chemoradiotherapy; Esophageal cancer; FOLFOX; Paclitaxel-carboplatin; Randomized trial

PMID:
27194176
PMCID:
PMC4872363
DOI:
10.1186/s12885-016-2335-9
[Indexed for MEDLINE]
Free PMC Article

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