Study Comparing Radiochemotherapy With Folfox 4 Regimen or 5FU-Cisplatin in Patients With Inoperable Esophageal Cancer
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00160030
First received: September 9, 2005
Last updated: December 4, 2009
Last verified: December 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Neoplasms |
Drug: FOLFOX 4 Drug: 5-FU / Cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Percentage of patients having completed the full treatment and Endoscopic complete response rate [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity profile (NCI-CTC). [ Time Frame: evaluated each week ] [ Designated as safety issue: Yes ]
| Enrollment: | 97 |
| Study Start Date: | September 2004 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
|
| Active Comparator: 2 |
Drug: 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).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Affairs Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00160030 History of Changes |
| Other Study ID Numbers: | L_9326 |
| Study First Received: | September 9, 2005 |
| Last Updated: | December 4, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 23, 2013