Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT02359968
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02359968
Study Brief:
Protocol Section:
NCT02359968