Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Biomarker/Laboratory analysis, Treatment Active 18 to 75 Other SWS-SAKK-16/00 EU-20138, NCT00030771

Objectives

1. Compare the feasibility and efficacy of neoadjuvant chemotherapy with or without radiotherapy, in terms of event-free survival, in patients with stage IIIA non-small cell lung cancer with mediastinal lymph node metastases.
2. Determine the value of positron emission tomography scans for predicting pathological response and event-free survival in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the objective response rate, failure pattern, and overall survival in patients treated with these regimens.
5. Compare the amount of serum DNA of patients treated with these regimens.
6. Correlate the DNA variation with tumor response, remission duration, and overall survival.
7. Evaluate specific serum DNA markers (i.e., beta-tubulin-, p53-, ras-mutation, DAP kinase-, CDKN2 hypermethylation present in the primary tumors) for predictivity.

Entry Criteria

Disease Characteristics:

• Histologically 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

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

Patient Characteristics:

Age:

• 18 to 75

Performance status:

• WHO 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm³
• Platelet count at least 100,000/mm³

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

Expected Enrollment

A total of 120 patients (60 per treatment arm) will be accrued for this study within 4 years.

Outcomes

Event-free survival
Operability after chemotherapy

Postoperative mortality assessed 30 days after surgery
Toxicity
Complete resection rate after surgery
Objective response rate measured after completion of chemoradiotherapy

Outline

This is a randomized, multicenter study. 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.

• Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Three weeks after the last chemotherapy administration, patients undergo radiotherapy once daily 5 days a week for 3 weeks and boost radiotherapy on days 2, 5, 9, 12, 15, 17, and 19 during the same 3 weeks.



• Arm II: Patients receive chemotherapy as in arm I.

All patients undergo surgical resection and mediastinal lymph node dissection within 21-28 days after completion of radiotherapy (arm I) or within 21 days after completion of chemotherapy (arm II).

All patients undergo blood collection periodically for translational research studies.

Patients are followed at 1 month and then every 3 months thereafter.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Miklos Pless, MD, Protocol chair		Ph: 41-52-266-2552 Email: miklos.pless@ksw.ch

Switzerland
	Aarau
	Kantonspital Aarau
		Walter Mingrone, MD	Ph:  41-62-838-6050
	Baden
		Antoinette Streit, MD	Ph:  41-56-221-1474
	Kantonsspital Baden
		Clemens Caspar, MD	Ph:  41-56-486-2511
	Basel
	Saint Claraspital AG
		Christian Ludwig, MD	Ph:  41-61-691-8585
			Email: christian.ludwig@claraspital.ch
	Universitaetsspital-Basel
		Cornelia Droege, MD	Ph:  41-61-265-5075
			Email: cdroege@uhbs.ch
	Bern
	Inselspital Bern
		Adrian Ochsenbein, MD	Ph:  41-31-632-8169
			Email: adrian.ochsenbein@insel.ch
	Bruderholz
	Kantonsspital Bruderholz
		Lorenz Jost, MD	Ph:  41-61-436-3636
			Email: lorenz.jost@ksbh.ch
	Geneva
	Hopital Cantonal Universitaire de Geneve
		Arnaud Roth, MD	Ph:  41-22-372-7744
			Email: arnaud.roth@sim.hcuge.ch
	Liestal
	Kantonsspital Liestal
		Andreas Lohri, MD	Ph:  41-61-925-2710
			Email: andreas.lohri@ksli.ch
	Thun
	Regionalspital
		Daniel Rauch	Ph:  41-33-226-2626
	Winterthur
	Kantonsspital Winterthur
		Miklos Pless, MD	Ph:  41-52-266-2552
			Email: miklos.pless@ksw.ch

Registry 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
Trial Start Date		2001-04-04
Trial Completion Date		2010-11-30 (estimated)
Registered in ClinicalTrials.gov		NCT00030771
Date Submitted to PDQ		2001-12-14
Information Last Verified		2007-10-07

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