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

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Oscar Lambret
• Collaborator: National Cancer Institute, France
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin; Paclitaxel

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 IIB (T1 N1 M0 or T2 N1 M0),

• stage III (T3 N1 M0 or T4 N0 N1 M0) tumors (appendix 5)

• ECOG performance status 0, 1 or 2 (appendix 7)

• Patient eligible for preoperative chemoradiation with either fluorouracil- oxaliplatin-folinic acid, or Paclitaxel-carboplatin

• Age ≥ 18 and ≤ 75 years

• Peripheral neuropathy ≤ NCI-CTC grade 1 (appendix 3)

• 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 (appendix 6)

• 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 of inclusion

• Negative pregnancy test (serum beta-HCG) performed within 1 week prior to start of study treatment in females with reproductive potential

Exclusion Criteria:

• Patient who present with stage I or stage IIA (including T3 N0) 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: