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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)

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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)


- 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

- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Paul A. Bunn, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Colorado, Denver


United States: Federal Government

Study ID:




Start Date:

October 1999

Completion Date:

November 2012

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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