Surgery With or Without Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Southwest Oncology Group National Cancer Institute (NCI) Eastern Cooperative Oncology Group North Central Cancer Treatment Group Radiation Therapy Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004011

Purpose

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	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery	Phase III

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Paclitaxel Carboplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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)

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

October 1999

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

Investigators

Study Chair:	Paul A. Bunn, MD	University of Colorado at Denver and Health Sciences Center
Study Chair:	Joseph A. Treat, MD	Fox Chase Cancer Center CCOP Research Base
Study Chair:	Randolph S. Marks, MD	Mayo Clinic
Study Chair:	Corey J. Langer, MD	Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000067223, SWOG-S9900, ECOG-S9900, NCCTG-S9900, RTOG-L0015
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004011 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carboplatin
Antimitotic Agents
Carcinoma
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel

Lung Diseases
Tubulin Modulators
Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Therapeutic Uses
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009