Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer

Esophageal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00160030
• Other study ID #: L_9326
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: December 4, 2009
• Start date: September 2004

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• 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)

• Creatinine levels <= 1.5 x the upper normal limit of institutional values (ULN)

• Total bilirubin level < 1.5 x ULN

• ALT/AST < 2.5 x ULN

• Prothrombin time >= 60%

• Laboratory values obtained the week preceding study entry

• Signed informed consent (prior to all study procedures)

• Start of treatment within 28 days of inclusion.

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)

• Prior cervical, thoracic and abdominal radiotherapy with field overlapping the proposed oesophageal radiotherapy field

• Tracheo-oesophageal fistula or invasion of the tracheo-bronchial tree

• Previous myocardial infarction (inferior or equal to 6 months). Patients with a previous myocardial infarction superior to 6 months, could be included only if: no transient ischemia is shown by thallium myocardial scintigraphy and favourable advice for chemotherapy is obtained from a cardiologist.

• Other serious illness or medical conditions (such as symptomatic coronary disease, left ventricular failure or uncontrolled infection)

• Arterial disease stage II to IV according to the Leriche and Fontaine classification

• Treatment with any other experimental drugs or participation in another clinical trial within 30 days of study screening

• Concurrent treatment with any other anti-cancer therapy

• Concurrent treatment with phenytoin and yellow fever vaccine; geographical, social or psychological circumstances preventing regular follow-up.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Drug:
• FOLFOX 4
total treatment of six 2-weekly cycles of FOLFOX 4, the first 3 cycles starting on D1, D15 and D29 concomitant with 5 weeks' radiotherapy.
• 5-FU / Cisplatin
two cycles of 5-FU / Cisplatin on week 1 and 5 of radiotherapy and two cycles of chemotherapy with 5-FU / Cisplatin on week 8 and 11 (one cycle each three weeks after the end of radiotherapy).

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients having completed the full treatment and Endoscopic complete response rate		at the end of the study	No
Secondary	Toxicity profile (NCI-CTC).		evaluated each week	Yes