Phase II Study Comparing Radiochemotherapy With the Folfox 4 Regimen Versus Radiochemotherapy With 5FU-Cisplatin (Herskovic Regimen) in First Line Treatment of Patients With Inoperable Esophageal Cancer

Sanofi1 site in 1 country97 target enrollmentSeptember 2004

ConditionsEsophageal Neoplasms

InterventionsFOLFOX 4 5-FU / Cisplatin

DrugsFOLFOX 4 5-FU / Cisplatin

Overview

Phase: Phase 2
Intervention: FOLFOX 4
Conditions: Esophageal Neoplasms
Sponsor: Sanofi
Enrollment: 97
Locations: 1
Primary Endpoint: Percentage of patients having completed the full treatment and Endoscopic complete response rate
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objectives of this study are to assess the feasibility (completion of full treatment) in both arms and to assess endoscopic complete response rate in both arms.

The secondary objective of this study is to assess the toxicity profile of each arm using the National Cancer Institute-Common Toxicity Criteria (NCI-CTC) scale (V.3).

Registry

clinicaltrials.gov

Start Date

September 2004

End Date

October 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility Criteria

Inclusion Criteria

•Patients with:
•Histologically proven adenocarcinoma, squamous cell or adenosquamous carcinoma of the esophagus
•Inoperable esophageal carcinoma (disease status: any T, N0 or N1, M0 or M1a) or surgical contraindication conditions
•No prior treatment for esophageal cancer (surgery, laser, chemo- or radiotherapy)
•Oesophageal dilatation is allowed before or during the treatment, but prior esophageal prosthesis is not allowed
•Peripheral neuropathy \<= NCI-CTC grade 1
•Age \>= 18 years
•Eastern Cooperative Oncology Group (ECOG) performance status (PS) \<= 2
•Sufficient (oral or with gastrostomy) calorific intake (\> 1000 Kcal/m2/day)
•Life expectancy \>= 3 months

Exclusion Criteria

•Metastatic disease except for third upper or cervical esophagus tumor with regional nodes, or third lower esophagus tumor with celiac nodes (M1a)
•Multiple carcinomas of the esophagus
•Small cell or undifferentiated carcinoma of the esophagus
•Complete dysphagia (grade 4 NCI-CTC); patient with exclusive parenteral nutrition.
•Weight loss \> 20% normal body weight
•Pregnant or breast-feeding women
•Fertile patient not using adequate contraception
•Peripheral sensitive neuropathy with functional impairment
•Auditory disorders
•History of prior malignancies (other than cured non melanoma skin cancer, cured cervical carcinoma in situ or stage I or II node negative head and neck cancer cured \> 3 years ago)