This trial is active, not recruiting.

Condition lung cancer
Treatments chemotherapy, radiotherapy, surgery
Phase phase 3
Sponsor Swiss Group for Clinical Cancer Research
Start date April 2001
End date October 2013
Trial size 232 participants
Trial identifier NCT00030771, EU-20138, SAKK 16/00, SWS-SAKK-16/00


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery
Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
3-4 weeks after termination of radiotherapy
(Active Comparator)
Neoadjuvant Chemotherapy + Surgery
Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days
3-4 weeks after termination of radiotherapy

Primary Outcomes

Event-free survival
time frame: 1 month after surgery

Secondary Outcomes

Postoperative mortality assessed
time frame: 1 month after surgery
time frame: During treatment
Complete resection rate after surgery
time frame: 1 month after surgery
Objective response rate measured after completion of chemoradiotherapy
time frame: 43 days
time frame: 1 month after chemo
Overall survival
time frame: Follow-up until death of patient
Failure pattern
time frame: Follow-up until death

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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 psychotic disorders - No dementia - No seizures Other: - No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years - No active uncontrolled infection - No uncontrolled diabetes mellitus - No gastric ulcers - No pre-existing peripheral neuropathy greater than grade 1 - No contraindications to corticosteroids - No other serious underlying medical condition that would preclude study participation - No socioeconomic or geographic condition that would preclude study participation - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior cytostatic chemotherapy Endocrine therapy: - No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent) Radiotherapy: - No prior radiotherapy to chest Surgery: - Not specified Other: - At least 30 days since participation in another clinical study - No other concurrent experimental drugs

Additional Information

Official title Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Non-small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial
Principal investigator Hans-Beat Ris, MD
Description The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44 Gy concomitant boost to neoadjuvant chemotherapy alone. Secondary objectives are to assess the value of PET in predicting pathological response and eventfree survival in stage IIIA NSCLC, and a health economic analysis of the two regimens. Further to compare the amount of serum DNA in patients with stage IIIA, pN2 NSCLC before chemotherapy, before surgery and at the second follow-up visit (i.e. four months after surgery or treatment failure for patients who can not be operated) in patients randomized into the trial SAKK 16/00 and to correlate the DNA variation with tumor response, remission duration and overall survival. OUTLINE: This is a prospective randomized phase III trial. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Swiss Group for Clinical Cancer Research.