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Clinical Trials (PDQ®)

  • Last Modified: 2/1/1994

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Clinical Trials (PDQ®)

Phase III Randomized Comparison of Pre- and Postoperative Chemotherapy with VP-16/CBDCA vs Surgery Alone in Patients with Operable Nonsmall Cell Carcinoma of the Lung (Summary Last Modified 02/94)

Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCISWOG-9015

Objectives

I.  Compare the survival of patients with clinical Stages IB, II, and IIIA 
nonsmall cell lung cancer randomized to treatment with etoposide/carboplatin 
pre- and postoperatively vs. surgery alone.

II.  Estimate the response rate of these patients to preoperative chemotherapy.

III.  Evaluate the association between the response to preoperative 
chemotherapy and survival in patients on the chemotherapy arm.

IV.  Assess the toxicity, including operative complications,
among patients on the chemotherapy arm.

Entry Criteria

Disease Characteristics:


Histologically or cytologically proven T2-3 N0 and T1-3 N1
nonsmall cell lung cancer (Clinical Stages IB, II, and IIIA
according to the 1986 International Staging System)

Minimal required staging includes chest x-ray and CT and
mediastinal exploration (mediastinoscopy and/or mediastinotomy;
patients randomized to Arm II may delay mediastinal exploration
until surgery)

  All accessible mediastinal nodes greater than 1.0 cm on
  imaging must be biopsy negative

  Hilar nodes greater than 1.5 cm on imaging are considered N1

  M0 status must be established by the following:
      History and physical exam

      Routine clinical chemistries (elevated alkaline
      phosphates requires bone scan)

      CT of chest and upper abdomen (including liver, celiac
      nodes, and adrenals)

      Any abnormality possibly representing metastatic disease
      must be negative on biopsy or aspiration cytology

Measurable or evaluable disease required


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy for lung cancer

Endocrine therapy:
  Not specified

Radiotherapy:
  No prior radiotherapy for lung cancer

Surgery:
  No prior surgery for lung cancer


Patient Characteristics:


Age:
  18 and over

Performance status:
  SWOG 0-2

Hematopoietic:
  WBC at least 4,000
  Platelets above institutional lower limit of normal

Hepatic:
  Bilirubin within institutional normal limits

Renal:
  Creatinine within institutional normal limits

Cardiovascular:
  Adequate cardiac function for planned surgery required
  No MI within 3 months
  No refractory CHF
  No cardiac arrhythmia
  No symptomatic coronary artery disease

Pulmonary:
  Adequate pulmonary function for planned surgery required
  FEV1 greater than 2,000 ml
     If less than 2,000 ml, the predicted postresection FEV1
     must be greater than 800 ml (predicted postresection FEV1
     = preoperative FEV1 x % uninvolved lung determined by
     quantitative lung V/Q scan)

Neurologic:
  No significant hearing loss such that the patient is
  unwilling to accept potential worsening

  No symptomatic peripheral neuropathy

Other:
  No uncontrolled medical illness (e.g., serious infection)
  No prior malignancy within 5 years except:
     Adequately treated nonmelanomatous skin cancer
     Adequately treated in situ cervical cancer
  No pregnant or lactating women
  Effective contraception required of all fertile patients

Blood/body fluid analyses to determine eligibility completed
within 21 days prior to registration; imaging studies and
physical exams for tumor measurement completed within 28 days
prior to registration; screening exams other than blood/body
fluid analyses and imaging studies of nonmeasurable disease or
uninvolved organs completed within 42 days prior to
registration


Expected Enrollment

200 patients will be required on each arm.  An annual accrual rate of 100 
patients is anticipated.

Outline

Randomized study.

Arm I:  2-Drug Combination Chemotherapy followed by Surgery followed by 2-Drug 
Combination Chemotherapy.  Etoposide, VP-16, NSC-141540; Carboplatin, CBDCA, 
NSC-241240; followed by resection of all gross tumor; followed by VP-16; CBDCA.

Arm II:  Surgery.  Resection of all gross tumor.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Paul Bunn, MD, Protocol chair
Ph: 303-724-4498; 800-473-2288
Email: paul.bunn@ucdenver.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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