Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Giving combination chemotherapy with radiation therapy before and after surgery may shrink
      the tumor so it can be removed during surgery and may kill any remaining tumor cells
      following surgery.

      PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin
      with radiation therapy and surgery in treating patients who have newly diagnosed locally
      advanced non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the complete resection rate and toxic death rate of patients with locally
           advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and
           radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.

        -  Determine the survival, event-free survival, and incidence of pathologic complete
           remission of patients treated with this regimen.

        -  Determine the protocol completion rate (CR) of patients treated with this regimen.

        -  Determine the feasibility and toxicity of this regimen in these patients.

        -  Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom
           from distant metastasis rate, and freedom from local regional failure rate of patients
           treated with this regimen.

      OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6
      weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22,
      29, and 36.

      Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients
      with resectable disease undergo surgical resection within 4-8 weeks after induction therapy.
      Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks
      and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

      Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant
      therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant
      treatment repeats every 4 weeks for 3 courses.

      Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
      annually thereafter.

      PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.
    

Intervention name(s): carboplatin; paclitaxel; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer