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
|Phase III||Treatment||Closed||18 and over||NCI||SWOG-9015|
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.
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
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
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
200 patients will be required on each arm. An annual accrual rate of 100 patients is anticipated.
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
Ph: 303-724-4498; 800-473-2288
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.