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

Launched by CENTRE OSCAR LAMBRET · Feb 9, 2015

Keywords

ClinConnect Summary

There is no standard preoperative (neoadjuvant) chemoradiation (NCRT) regimen for resectable esophageal cancer, because most if all trials failed to show any survival advantage favoring pCRT when compared to surgery only. This failure had been related to the lack of power of some trials, as well as the ability of chemoradiation to potentiate post-operative morbidity (including mortality), and therefore hampering the accrual of its own survival benefit. Hopefully, meta-analyses showed that NCRT increases survival when compared to surgery only. However, in the clinical practice, this does not...

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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