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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Esophageal Neoplasms

Treatments

Drug: FOLFOX 4

Drug: 5-FU / Cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00160030

L_9326

Details and patient eligibility

About

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).

Enrollment

97 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.