A Two Arm Phase II Study Comparing Docetaxel/Cisplatin Induction Therapy Followed By Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy Followed By Consolidation Docetaxel/Cisplatin in Patients With Locally Advanced Unresectable NSCLC (Stage IIIA-Multiple cN2 or IIIB)
- Histologically or cytologically confirmed NSCLC (adenocarcinoma, squamous cell
carcinoma, large cell carcinoma or a combination of these)
- Patients must have a locoregionally advanced unresectable NSCLC
- Stage IIIA with multiple level clinical N2 nodes (preferably with histological
or cytological confirmation).
- Patients with peripheral tumours of the lower lobe with contralateral upper
mediastinal nodes at station N2 are excluded
- Stage IIIB T4 or N3
- In the T4 category, patients with pleural or pericardial effusion and
multiple nodules in the same lobe are excluded.
- Patients with T4 disease secondary to extensive and massive involvement of
the great vessels are excluded.
Patients should be excluded when the expected risk of pulmonary toxicity is likely to be
high, e.g. V20 in excess of 35%.
- Life expectancy of at least 12 weeks.
- WHO performance status 0 or 1.
- Weight loss ≤ 10% within the last 3 months.
- Laboratory requirements at entry (within 7 days before randomization):
- Blood cell counts:
- Absolute neutrophils ≥ 2.0 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/dl
- Renal function:
_Serum creatinine ≤1 x the upper limit of normal (UNL). In case of borderline
value of serum creatinine, the 24h creatinine clearance should be ≥ 60 mL/min
- Hepatic functions:
- Serum bilirubin ≤ 1 x UNL
- ASAT and ALAT ≤ 2.5 x UNL
- Alkaline phosphatase ≤ 5 x UNL.
Patients with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x
UNL are not eligible for the study.
- Lung function tests at entry:
- FEV1: ≥ 50 % x Normal value
- DLco: ≥ 50 % x Normal value.
- Adequate cardiac function.
- Patient with either measurable and/or non-measurable lesion (according to RECIST
- Diagnosis of small cell lung cancer
- Pregnant or lactating women
- Patients (male or female) with reproductive potential not implementing adequate
- Prior systemic chemotherapy, immunotherapy, or biological therapy including
neoadjuvant or adjuvant treatment for NSCLC
- Prior surgery for NSCLC, if less than 5 years from study
- Prior radiotherapy for NSCLC
- History of prior malignancies, except for cured non-melanoma skin cancer, curatively
treated in situ carcinoma of the cervix or other cancer curatively treated and with
no evidence of disease for at least five years.
- Symptomatic peripheral neuropathy Grade ≥ 2 except if due to trauma.
- Other serious concomitant illness of medical conditions:
- Congestive heart failure or angina pectoris except if it is medically
controlled. Previous history of myocardial infarction within 1 year from study
entry, uncontrolled hypertension or arrhythmias.
- History of significant neurologic or psychiatric disorders including dementia or
- Active infection requiring IV antibiotics.
- Active ulcer, unstable diabetes mellitus or other contra-indication to
- Superior vena cava syndrome contra-indicating hydration.
- Preexisting pericardial effusion.
- Preexisting symptomatic pleural effusion.
- Significant gastrointestinal abnormalities, including requirement for intravenous
nutrition, active peptic ulcer disease, prior surgical procedures affecting
- Distant metastasis.
- Concurrent treatment with any other experimental anti-cancer drugs.
- Concomitant or within 4-week period administration of any other experimental drug
- Significant ophthalmologic abnormalities.
- Moderate to severe dermatitis.
- Hypersensitivity to docetaxel or any of its excipients.
- Concomitant use of phenytoin, carbamazepin, barbiturates, or rifampicin.
- Mental condition rendering the patient unable to understand the nature, scope, and
possible consequences of the study.
- Patient unlikely to comply with protocol, i.e., uncooperative attitude, inability to
return for follow-up visits, and unlikelihood of completing the study.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.