Status and phase
Conditions
Treatments
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
Sex
Ages
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:
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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
97 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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