Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase II Trial
Inclusion Criteria:
- Histologically proven NSCLC with nodal metastases: T1-3N2M0
- Performance status 0-1
- Patient medically fit enough for protocol therapy, including operability
- Age 18-75
- Written informed consent
- No previous chemo- or radiotherapy
Exclusion Criteria:
- Patients with prior or concomitant malignancies Allowed are: non-melanomatous skin
cancer, adequately treated in situ cervical cancer or any other neoplastic diseases
with disease-free interval ³ 5 years.
- Presence or history of any distant metastasis
- Unstable cardiac disease requiring treatment, congestive heart failure or angina
pectoris even if medically controlled, significant arrhythmia, or prior history of
myocardial infarction in the last 3 months
- History of significant neurologic or psychiatric disorders including psychotic
disorders, dementia or seizures that would prohibit the understanding and giving of
informed consent
- Active uncontrolled infection
- Uncontrolled diabetes mellitus
- Gastric ulcers
- Preexisting peripheral neuropathy (> grade 1)
- Other serious underlying medical condition which could impair the ability of the
patient to participate in the trial
- Concurrent treatment with other experimental drugs
- Pretreatment with any other cytostatic therapy
- Previous radiotherapy to the chest
- Concurrent treatment with prednisone (or equivalent) except: for the prophylactic
medication regimen before treatment, treatment of acute hypersensitivity reactions or
chronic treatment (initiated > 6 months prior to trial entry) at low dose (£ 20 mg
methylprednisolone or equivalent)
- Definite contraindications for the use of corticosteroids as premedication
- Treatment within a clinical trial within 30 days prior to trial entry
- Socioeconomic or geographic circumstances that may prohibit proper staging, treatment
or follow-up procedures
- Pregnancy, lactation period