CompletedPhase 3

Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients

Germany, Serbia, Switzerland232 participantsStarted 2001-04-04

Plain-language summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Squamous, adenosquamous, large cell, or poorly differentiated * Stage IIIA (T1-3, N2, M0) * N2 disease confirmed by 1 of the following: * Mediastinoscopy * Bronchoscopy with fine-needle aspiration or esophagoscopy * All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (\< 1 cm in the largest diameter) * PET scan * Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan * At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (\> 1 cm in the largest diameter) * All N3 lymph nodes negative in PET scan PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * AST/ALT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * Cardiac function normal * No unstable cardiac disease requiring treatment * No congestive heart failure * No angina pectoris even if medically controlled * No significant arrhythmia * No myocardial infarction in the past 3 months Pulmonary: * Lung function appropriate Neurologic: * No history of significant neurologic or psychiatric disorders * No…

What they're measuring

Event-free survival

Timeframe: 1 month after surgery

Trial details

NCT IDNCT00030771

SponsorSwiss Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-04-09