Docetaxel in Non Small Cell Lung Cancer (NSCLC)

Study Overview
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Brief Summary
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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

Official Title
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Multicenter Phase II Study Evaluating Docetaxel and CDDP as Induction Regimen Prior to Surgery or Radiochemotherapy With Docetaxel, Followed by Adjuvant Docetaxel Therapy in Chemonaive Patients With NSCLC Stage II, IIIa and IIIb

Conditions
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Carcinoma, Squamous Cell

Intervention / Treatment
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* Drug: Docetaxel + CDDP
* Drug: docetaxel + CDDP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) 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: 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 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 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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Resectable NSCLC | Drug: Docetaxel + CDDP<br>* 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<br>|
| Experimental: 2<br>Unresectable NSCSC | Drug: docetaxel + CDDP<br>* 3 cycles chemotherapy: docetaxel + CDDP Radiochemotherapy 3 cycles adjuvant chemotherapy docetaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |