Official Title: “A Randomized Phase III Trial of Surgery Alone or Surgery Plus Preoperative Paclitaxel/Carboplatin in Clinical Stage IB (T2N0), II (T1-2N1, T3N0) and Selected IIIA (T3N1) Non-Small Cell Lung Cancer (NSCLC)”

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if surgery plus combination chemotherapy is more effective than surgery alone for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have non-small cell lung cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

OBJECTIVES: - Compare survival of patients with previously untreated stage IB, II, or selected IIIA non-small cell lung cancer after preoperative chemotherapy comprising paclitaxel and carboplatin plus surgery vs surgery alone. - Compare these regimens in terms of operative mortality and other toxic effects in these patients. - Evaluate the response rates (confirmed and unconfirmed) and toxic effects associated with combined paclitaxel and carboplatin in these patients. - Obtain samples for correlation of radiologic, pathologic, molecular, and biologic factors with the outcome in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to clinical stage (IB or IIA vs IIB or IIIA).

Patients are randomized to one of two treatment arms: - Arm I: Patients undergo thoracotomy. All accessible hilar (level 10) lymph nodes are dissected, and complete mediastinal lymph node sampling is performed. - Arm II: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 3 courses in the absence of disease progression or unacceptable toxicity. Within 2-6 weeks of course 3, patients undergo thoracotomy and lymph node dissection as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually until year 10.

PROJECTED ACCRUAL: A total of 600 patients (300 per treatment arm) will be accrued for this study within 4 years.

Intervention(s) in this Clinical Trial

• Drug: carboplatin
• Drug: paclitaxel
• Procedure: conventional surgery

DISEASE CHARACTERISTICS:

• Histologically or cytologically proven non-small cell lung cancer (NSCLC), meeting 1 of the following staging criteria:
• Stage IB (T2, N0)
• Stage II
• T1-2, N1 with negative mediastinoscopy OR
• T3, N0
• Selected stage IIIA with negative mediastinoscopies
• T3, N1, excluding superior sulcus
• Positive level 10 hilar nodes allowed if mediastinoscopy negative
• Apical tumors with no clinical symptoms allowed
• No symptomatic tumors (T3, N0 or T3, N1) involving the superior sulcus
• No Pancoast's tumors
• Negative mediastinoscopy required in all patients with clinically positive mediastinal or hilar lymph nodes to ensure no N2 disease
• Bidimensionally measurable or evaluable disease by chest x-ray or contrast-enhanced CT scan
• T3, N0 disease assessable only by bronchoscopy must be affirmed by 2 observers and documented by photograph that includes main carina

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• WBC at least 4,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2 times ULN
• Alkaline phosphatase no greater than 2 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN
• Creatinine clearance at least 50 mL/min

Pulmonary:

• See Disease Characteristics
• Preresection FEV_1 greater than 2.0 L OR
• Predicted postresection FEV_1 greater than 1.0 L
• No postobstructive pneumonia

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No serious infection
• No other serious medical condition that would preclude study compliance
• No prior allergic reactions to drugs containing Cremophor
• No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior systemic chemotherapy for NSCLC
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior systemic radiotherapy for NSCLC
• No concurrent radiotherapy

Surgery:

• At least 5 years since prior resection of lung disease

Other:

• No other concurrent investigational therapy
• No other concurrent anticancer therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Southwest Oncology Group

Overall Clinical Trial Officials and Contacts

Paul A. Bunn, MD Study Chair University of Colorado at Denver and Health Sciences Center  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00004011

Study ID Number: CDR0000067223

ClinicalTrials.gov Identifier: NCT00004011

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database