Clinical trial · Interventional
PReoperative Chemoradiation (Paclitaxel-carboplatin or FOLFOX) for Resectable Esophageal and Junctional Cancer
PReoperative Chemoradiation With Paclitaxel-carboplatin or With Fluorouracil-oxaliplatine-acide Folinique (FOLFOX) for Resectable Esophageal and Junctional Cancer - A Randomized Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gastro-esophageal Junction Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CarboP-pacliT | Drug | — | UNRESOLVED |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX
- description
- * 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
- interventionNames
- Drug: FOLFOX
- type
- EXPERIMENTAL
- label
- CarboP-pacliT
- description
- * 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
- interventionNames
- Drug: CarboP-pacliT
Primary outcomes (1)
- measure
- Short-term benefit of 2 preoperative regimen: complete resection rate AND severe (grade ≥ 3) postoperative morbidity/mortality according to the Clavien-Dindo classification
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Clearance of creatinin (Cockcroft formulae) ≥ 60 ml/mn * Prothrombin time ≥ 60% * ASAT-ALAT ≤2.5 x ULN * Total bilirubin \< 1.5 x ULN * Albumin greater the lower limit of normal * Start of treatment within 28 days after randomization * Negative pregnancy test (serum beta-HCG) performed within 1 week prior to start of study treatment in females with reproductive potential * Patient covered by government health insurance * Patient who provide a signed written informed consent form Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDMessager 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