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

Alternate Title

Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 75 Other SWS-SAKK-16/01 EU-20137, NCT00030810

Objectives

1. Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
2. Determine the rate of event-free survival at 1 year in patients treated with this regimen.
3. Determine the operability and complete resection rate in patients treated with this regimen.
4. Determine the postoperative 30-day mortality in patients treated with this regimen.
5. Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
6. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed, operable stage IIIB non-small cell lung cancer
  • T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax
  • Squamous cell
  • Adenosquamous cell
  • Large cell
  • Poorly differentiated



• No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan



• No malignant pleural or pericardial effusion



• No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)

Radiotherapy:

• No prior radiotherapy to the chest

Surgery:

• See Disease Characteristics

Other:

• At least 30 days since prior treatment in a clinical trial
• No prior cytostatic therapy
• 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 and/or ALT no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No unstable cardiac disease requiring treatment
• No congestive heart failure
• No angina pectoris (even if medically controlled)
• No significant arrhythmia
• No myocardial infarction within the past 3 months

Other:

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No definite contraindications for the use of corticosteroids as premedication
• No preexisting grade 2 or greater peripheral neuropathy
• No active uncontrolled infection
• No uncontrolled diabetes mellitus
• No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix
• No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent
• No other serious underlying medical condition that would preclude study participation
• No socioeconomic or geographical circumstances that would preclude study compliance

Expected Enrollment

A total of 15-46 patients will be accrued for this study.

Outcomes

Rate of event-free survival measured 1 year after registration

Operability after chemotherapy
Postoperative mortality 30 days after surgery
Complete resection rate after surgery
Toxicity
Response rate

Outline

This is a multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

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

Pless M, Stupp R, Kann R, et al.: Preoperative chemoradiotherapy in non-small cell lung cancer (NSCLC) patients with operable stage IIIB disease: a phase II trial of the Swiss Group for Clinical Cancer Research (SAKK). [Abstract] J Clin Oncol 25 (Suppl 18): A-18021, 685s, 2007.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Roger Stupp, MD, Protocol chair		Ph: 41-21-314-0156 Email: roger.stupp@chuv.ch

Registry Information
Official Title		Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial
Trial Start Date		2001-09-05
Registered in ClinicalTrials.gov		NCT00030810
Date Submitted to PDQ		2001-12-11
Information Last Verified		2006-10-01

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