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

NCT00160030 | Completed Phase 2

• 1 other identifier: L_9326
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

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).

Conditions

Esophageal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Percentage of patients having completed the full treatment and Endoscopic complete response rate

  at the end of the study

Secondary Outcomes (1)

• Toxicity profile (NCI-CTC).

  evaluated each week

Study Arms (2)

1

EXPERIMENTAL

Drug: FOLFOX 4

2

ACTIVE COMPARATOR

Drug: 5-FU / Cisplatin

Interventions

FOLFOX 4 DRUG

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.

1

5-FU / Cisplatin DRUG

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).

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Marie SEBILLE

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2004
• Primary Completion: October 1, 2007
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

FR (1)