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

Alternate Title

Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

Basic Trial Information

Special Category: CTSU trial

Objectives

1. 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.
2. Compare these regimens in terms of operative mortality and other toxic effects in these patients.
3. Evaluate the response rates (confirmed and unconfirmed) and toxic effects associated with combined paclitaxel and carboplatin in these patients.
4. Obtain samples for correlation of radiologic, pathologic, molecular, and biologic factors with the outcome in patients treated with these regimens.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Zubrod 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• WBC at least 4,000/mm³

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 FEV₁ greater than 2.0 L

  OR

• Predicted postresection FEV₁ 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

Expected Enrollment

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

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.

Pisters KM, Vallières E, Crowley JJ, et al.: Surgery with or without preoperative paclitaxel and carboplatin in early-stage non-small-cell lung cancer: Southwest Oncology Group Trial S9900, an intergroup, randomized, phase III trial. J Clin Oncol 28 (11): 1843-9, 2010.[PUBMED Abstract]

Pisters K, Vallieres E, Bunn PA, et al.: S9900: surgery alone or surgery plus induction (ind) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): follow-up on a phase III trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-7520, 389s, 2007.

Pisters K, Vallieres E, Bunn P, et al.: S9900: a phase III trial of surgery alone or surgery plus preoperative (preop) paclitaxel/carboplatin (PC) chemotherapy in early stage non-small cell lung cancer (NSCLC): preliminary results. [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7012, 624s, 2005.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Paul Bunn, MD, Protocol chair		Ph: 303-724-3155; 800-473-2288 Email: paul.bunn@ucdenver.edu

Eastern Cooperative Oncology Group

Joseph Treat, MD, Protocol chair		Ph: 215-707-8030

North Central Cancer Treatment Group

Randolph Marks, MD, Protocol chair		Ph: 507-284-2511

Radiation Therapy Oncology Group

Corey Langer, MD, Protocol chair		Ph: 215-728-2985; 888-369-2427 Email: cj_langer@fccc.edu

Registry Information
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)
Trial Start Date		1999-10-15
Registered in ClinicalTrials.gov		NCT00004011
Date Submitted to PDQ		1999-07-26
Information Last Verified		2004-08-19
NCI Grant/Contract Number		CA32102

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