NCT02359968CompletedPhase 2
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 · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 12 Jan 2015
- Start date
- 26 Feb 2015
- Primary completion date
- 8 Jan 2021
- Lead sponsor
- Centre Oscar Lambret
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT02359968
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 106
- From 26 Feb 2015 to the primary completion date, 8 Jan 2021
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient who present with common contraindications for surgery related to patient status
Other illness
- Patient who present with common contraindications for surgery related to disease extension
Other
- Patient who present with stage I or stage IIA (including T2 N0 M0) or stage IV
- Patient who present with common contraindication to radiochemotherapy with either fluorouracile-cisplatin or with paclitaxel-carboplatin
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| ICO Paul Papin Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Oscar Lambret Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| University Hospital of Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Nord Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| Hôpital la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| ICM Val d'Aurelle Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CH Lyon Sud Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| Centre Eugène Marquis Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| Ico Rene Gauducheau Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.