Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases

Study Overview
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Brief Summary
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The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone. Secondary objectives are to assess the value of position emission tomography (PET）in predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic acid (DNA) variation with tumor response, remission duration and overall survival.

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Radiation: neoadjuvant chemoradiotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: neoadjuvant chemotherapy<br>Chemotherapy Docetaxel 75 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days | Radiation: neoadjuvant chemoradiotherapy<br>* Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks<br>|
| Experimental: neoadjuvant chemoradiotherapy<br>Docetaxel 75 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days | Radiation: neoadjuvant chemoradiotherapy<br>* Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  | five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operability |  | within the first 30 days (plus or minus 3 days) after surgery | 
| Postoperative 30-day mortality |  | 30 days after treatment | 
| Toxicity |  | 30 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preoperative chemoradiotherapy, stage IIIA, N2