Stereotactic Radiosurgery in Treating Patients Undergoing Chemotherapy and Radiation Therapy For Stage III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Primary Evaluate the maximum tolerated dose of stereotactic radiosurgery in patients with locally advanced non-small cell lung cancer undergoing concurrent chemoradiotherapy. (Phase I) Assess the response rate (complete and partial response) in these patients by RECIST criteria. (Phase II) Secondary Determine the tolerability. (Phase I) Assess the quality of life of these patients by QLQ-C30 v3. (Phase I) Assess the overall and disease-free survival of these patients. (Phase II) Assess progression-free survival of these patients. (Phase II) OUTLINE: This is a multicenter, phase I dose escalation study of stereotactic radiosurgery followed by a phase II study. Patients receive docetaxel IV and cisplatin IV on days 1, 22, 43, 50, 57, and 64 in the absence of disease progression or unacceptable toxicity. Beginning on day 43, patients undergo concurrent radiotherapy to the mediastinum 5 days a week. Beginning 2-3 weeks after chemoradiotherapy, patients undergo stereotactic radiosurgery on days 1, 3, and 5. Quality of life is assessed by the QLQ-C30 v3 questionnaire at baseline, after radiosurgery, and at 6 and 12 months after completion of study treatment. After completion of study treatment, patients are followed up monthly for 6 months, every 3 months for 1 year, and then every 6 months for 3 years.

Official Title
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Study of Doses Escalation on Efficacy on Cyberknife After Docetaxel-Cisplatin Concomitant Radiotherapy for Non Small Cells Lung Cancer Stage III

Conditions
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Lung Cancer

Intervention / Treatment
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* Device: CK


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer Locally advanced disease No metastatic disease Unable to undergo surgery after concurrent chemoradiotherapy Must have 1-3 tumor target masses < 5 cm in greatest diameter and separated by ≥ 2 cm after concurrent chemoradiotherapy PATIENT CHARACTERISTICS: WHO performance status 0-2 Platelet count > 100,000/mm³ Hemoglobin > 9 g/dL Neutrophil > 1.0 x 10^9/L FEV_1 > 30% of vital capacity Vital capacity > 25% of predicted value DLCO > 25% of predicted value LVEF ≥ 35% PT > 80 aPTT > 35 sec Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after completion of study treatment Not under guardianship No dyspnea related to NYHA class III-IV heart failure No indirect signs of pulmonary arterial hypertension (pulmonary arterial systolic BP > 45 mm Hg) No pulmonary acceleration time < 100 ms No contraindication to fiducial insertion No geographical, social, or psychological conditions that would interfere with medical follow-up PRIOR CONCURRENT THERAPY: Docetaxel and platinum-based drugs with concurrent irradiation allowed No prior surgery or surgery after the first phase of treatment with concurrent chemoradiotherapy No prior irradiation to lung No concurrent participation in another study trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CyberKnife irradiation<br> | Device: CK<br>* Cyberknife Irradiation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose (phase I) |  | 5 years | 
| Overall response rate by RECIST (phase II) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage II non-small cell lung cancer