S9900: Surgery With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004011
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 31, 2013
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 354 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : October 1999
Actual Primary Completion Date : May 2005
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: preooperative chemo followed by surgery
carboplatin paclitaxel conventional surgery
Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery
Active Comparator: Surgery alone
conventional surgery
Procedure: conventional surgery

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • Not specified


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


  • 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


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


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


  • 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


Biologic therapy:

  • Not specified


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

Endocrine therapy:

  • Not specified


  • No prior systemic radiotherapy for NSCLC
  • No concurrent radiotherapy


  • At least 5 years since prior resection of lung disease


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004011

  Show 287 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
North Central Cancer Treatment Group
Radiation Therapy Oncology Group
Study Chair: Paul A. Bunn, MD University of Colorado, Denver
Study Chair: Joseph A. Treat, MD Fox Chase Cancer Center
Study Chair: Randolph S. Marks, MD Mayo Clinic
Study Chair: Corey J. Langer, MD Fox Chase Cancer Center

Publications of Results:
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.

Responsible Party: Southwest Oncology Group Identifier: NCT00004011     History of Changes
Other Study ID Numbers: CDR0000067223
S9900 ( Other Identifier: SWOG )
S9900 ( Other Identifier: ECOG )
S9900 ( Other Identifier: NCCTG )
RTOG-L0015 ( Other Identifier: RTOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Southwest Oncology Group:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action