Carcinoma, Squamous Cell
Conditions
Brief summary
Primary objective: • To assess the response rate to induction therapy with docetaxel/CDDP. Secondary objectives: To assess * Resectability after induction therapy * Time to progression * Overall survival * Safety profile * Quality of Life
Interventions
DRUGDocetaxel + CDDP
* 3 cycles chemotherapy : docetaxel + CDDP * Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered) * 3 cycles adjuvant chemotherapy docetaxel
DRUGdocetaxel + CDDP
* 3 cycles chemotherapy: docetaxel + CDDP * Radiochemotherapy * 3 cycles adjuvant chemotherapy docetaxel
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histology and staging of the disease * Histologically or cytologically confirmed NSCLC; histology may include: large cell, squamous cell or adenocarcinoma but no SCLC * Resectable or unresectable NSCLC stage II (T1-2 N1, T3 N0) or stage IIIa (T1-2 N2 or T3 N1-2) or stage IIIb (T1-3 N3 or T4 N0-3) * Measurable disease (bidimensionally or unidimensionally according to WHO criteria) 2. General conditions * Karnofsky Status \> 70, if age \> 70 years → PS \> 70 * Adequate hematological function (Hb \> 10 g/dl, ANC \> 2.0 x 109/L, platelets \> 100 x 109/L) * Adequate renal and hepatic functions: total bilirubin \< 1 x upper normal limit (UNL), serum creatinine \< 1 x UNL, in case of limit value the creatinine clearance should be \> 60 ml/min, ASAT and ALAT \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL.
Exclusion criteria
1. Diagnosis * Evidence of brain metastases or other distant metastasis equivalent to stage IV disease * History of prior malignancies, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix or other curatively treated cancer with no evidence of disease for at least five years * Other serious concomitant illness or medical condition: * Congestive heart failure or angina pectoris, except if medically controlled, history of myocardial infarction within 1 year from study entry, uncontrolled hypertension or arrhythmia * History of significant neurologic or psychiatric disorders, including dementia or seizure * Active infection requiring i.v. Antibiotics * Active ulcer, unstable diabetes mellitus or other contraindications to corticotherapy * Hepatic function abnormality: ASAT and/or ALAT \> 1.5 x UNL associated with alkaline phosphatase \> 2.5 x UNL * Current peripheral neuropathy WHO grade \> 2 2. Prior or concurrent therapy * Prior chemotherapy or immunotherapy for NSCLC, including neoadjuvant or adjuvant treatment * Prior surgery or radiotherapy for NSCLC * Concurrent treatment with other experimental drugs, unapproved medical procedures or other anticancer therapy 3. General conditions * Pregnant or lactating patients * Patients (M/F) with reproductive potential not implementing adequate contraceptive measurements The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the response rate to induction therapy with docetaxel in combination with CDDP | every 3 months until tumour progression and thereafter every 6 months until death |
Secondary
| Measure | Time frame |
|---|---|
| Resectability after induction therapy | every 3 months until tumour progression and thereafter every 6 months until death |
| Time to progression | every 3 months until tumour progression and thereafter every 6 months until death |
| Overall survival | every 3 months until tumour progression and thereafter every 6 months until death |
| Safety profile | throughout the study |
| Quality of life | every 3 months until tumour progression and thereafter every 6 months until death |
Countries
Austria
Outcome results
None listed