PReoperative Chemoradiation (Paclitaxel-carboplatin or FOLFOX) for Resectable Esophageal and Junctional Cancer

NCT02359968 | Completed Phase 2 DMC

• 3 other identifiers: PROTECT-1402PHRC-K14-0092017-A03112-51
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 10

Brief Summary

Resectable esophageal or junctional cancer requires medical treatment by radiotherapy and chemotherapy followed by surgery. Currently, one of the most commonly used chemotherapy treatment is the FOLFOX. It is a combination of three drugs administered intravenously: fluorouracil, oxaliplatin and folinic acid. This is the standard treatment. Another protocol of chemotherapy is widely used by certain European and American teams, due to promising results : a combination of two drugs administered intravenously: Paclitaxel and Carboplatin (CarboP-pacliT). At present, 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.

Conditions

Esophageal Neoplasms; Gastro-esophageal Junction Cancer

Keywords

resectable esophageal; junctional cancer; FOLFOX; paclitaxel-carboplatin

Outcome Measures

Primary Outcomes (1)

• Short-term benefit of 2 preoperative regimen: complete resection rate AND severe (grade ≥ 3) postoperative morbidity/mortality according to the Clavien-Dindo classification

  Complete resection rate (R0, that is "complete removal of all tumor with microscopic examination of margins showing no tumor cells") AND severe (grade ≥ 3) postoperative morbidity/mortality according to the Clavien-Dindo classification. Severe postoperative complication is defined by grade ≥III per-operative or post-operative complication occurring in the 30 days after surgery.

  up to 30 days after surgery

Secondary Outcomes (7)

• Rate of completion of full treatment without modification

  up to 58 days

• Evaluation of the efficacy of both regimen in term of overall survival

  From date of inclusion until the date of death from any cause assessed up to 36 months after the last surgery

• Evaluation of the efficacy of both regimen in term of disease-free survival

  From date of inclusion until the date of first documented progression whichever came first, assessed up to 36 months after the last surgery

• Evaluation of the safety of the evaluated regimens in terms of preoperative mortality.

  From registration to surgery

• Evaluation of the safety of the evaluated regimens in terms of preoperative morbidities, postoperative morbidities, respiratory morbidities.

  From start of treatment to end of study

Other Outcomes (4)

• DVH (CoDose-Volume-Histogram (DVH) and postoperative respiratory morbidity

  up to 30 days after the beginning of radiotherapy

• Comparison of both arms in terms of safety and efficacy

  From date of inclusion until the date of death from any cause assessed up to 36 months after the last surgery

• Net treatment benefit estimation

  From date of inclusion until the date of death from any cause assessed up to 36 months after the last surgery

Study Arms (2)

FOLFOX

ACTIVE COMPARATOR

* Fluorouracil 400 mg/m², IV bolus dose on day 1, followed by continuous IV infusion of fluorouracil 1600 mg/m² over 2 days * Oxaliplatin 85 mg/m², 2-hr IV infusion on day 1 * Folinic acid 200 mg/m² 2-hr IV infusion on day 1 * 3 cycles, q14

Drug: FOLFOX

CarboP-pacliT

EXPERIMENTAL

* Carboplatin (carboP) AUC=2, given by intravenous infusion * Paclitaxel (pacliT) 50 mg/m², given by intravenous infusion * on days 1, 8, 15, 22 and 29

Drug: CarboP-pacliT

Interventions

FOLFOX DRUG

radiochemotherapy before surgery

Also known as: Fluorouracil, Oxaliplatin, Folinic acid, Elvorine

FOLFOX

CarboP-pacliT DRUG

radiochemotherapy before surgery

Also known as: Carboplatine, paclitaxel

CarboP-pacliT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resectable and operable esophageal cancer located under the carena (beyond 25 cm from the incisors) or junctional cancer (Siewert I or II)
• Invasive adenocarcinoma or squamous cell type (to stick to the population included in the CROSS trial)
• Patient who present with:
• stage IIA (T3N0M0)
• stage IIB (T1 N1 M0 or T2 N1 M0),
• stage III (T3 N1 M0 or T4 N0 N1 M0) tumors
• ECOG performance status 0, 1 or 2
• Patient eligible for preoperative chemoradiation with either fluorouracil- oxaliplatin-folinic acid, or Paclitaxel-carboplatin
• Age ≥ 18
• Peripheral neuropathy ≤ NCI-CTC grade 1
• Adequate bone marrow reserve, normal renal and liver functions:
• Neutrophil count ≥ 1500/mm3
• Platelet count ≥ 100 000/mm3
• Hemoglobin ≥ 10 g/dl (after transfusion, if necessary)
• Creatinin \< 15mg/L

You may not qualify if:

• Patient who present with stage I or stage IIA (including T2 N0 M0) or stage IV
• Patient who present with common contraindications for surgery related to patient status
• Patient who present with common contraindications for surgery related to disease extension
• Patient who present with common contraindication to radiochemotherapy with either fluorouracile-cisplatin or with paclitaxel-carboplatin

Sponsors & Collaborators

• National Cancer Institute, France: collaborator
• Centre Oscar Lambret: lead

Study Sites (10)

ICO Paul Papin

Angers, France

Location

CHU Bordeaux

Bordeaux, France

Location

University Hospital of Lille

Lille, 59000, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Hôpital La Timone

Marseille, France

Location

Hôpital Nord

Marseille, France

Location

ICM - Val d'Aurelle

Montpellier, France

Location

CH Lyon sud

Pierre-Bénite, France

Location

Centre Eugène Marquis

Rennes, France

Location

ICO René Gauducheau

Saint-Herblain, France

Location

Related Publications (1)

• Messager M, Mirabel X, Tresch E, Paumier A, Vendrely V, Dahan L, Glehen O, Vasseur F, Lacornerie T, Piessen G, El Hajbi F, Robb WB, Clisant S, Kramar A, Mariette C, Adenis A. 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. 2016 May 18;16:318. doi: 10.1186/s12885-016-2335-9.

  PMID: 27194176 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Folfox protocol; Fluorouracil; Oxaliplatin; Leucovorin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Antoine ADENIS, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

• Guillaume PIESSEN, MD

  University Hospital of Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: February 10, 2015
• Study Start: February 26, 2015
• Primary Completion: January 8, 2021
• Study Completion: February 9, 2024
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)