Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

Study Overview
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Brief Summary
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The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.

Official Title
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A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)

Conditions
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Lung Cancer, Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Carboplatin
* Procedure: Radiation therapy
* Procedure: Surgical resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed stage IIIA or IIIB NSCLC Patients must have measurable disease No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC. Age>18 years Life expectancy >12 months ECOG performance status 0-1 Normal organ and marrow function Medically fit for surgery at time of enrollment. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment. Ability to understand and willingness to sign the consent form. Exclusion Criteria: Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC. Patients receiving any other investigational agents. Known metastatic disease (brain or any other site) History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study. Peripheral neuropathy >grade 1 Uncontrolled concurrent illness Pregnant women Weight loss>10% in the past 3 months before diagnosis. Hyperglycemia - exclusion from PET analysis HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.

Ages Eligible for Study
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Minimum Age: 18 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: Chemotherapy+Radiation+Surgery<br>Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support. | Drug: Docetaxel<br>* 20 mg/m2, 75 mg/m2 infusion<br>* Other names: Taxotere;Drug: Carboplatin<br>* AUC of 2 and 6 infusion<br>* Other names: Paraplatin;Procedure: Radiation therapy<br>* NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.<br>* Other names: radiotherapy;Procedure: Surgical resection<br>* All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.<br>* Other names: segmental resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy. | Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival | The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported. | baseline, 5 weeks after combined chemo-radiation |