Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of proton beam radiotherapy combined with chemotherapy for treatment of locally advanced non-small cell lung cancer.

Official Title
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Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma

Conditions
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Locally Advanced Non-Small Cell Lung Cancer

Intervention / Treatment
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* Radiation: Proton Radiation Therapy
* Drug: Taxol
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical stage 2, 3A or 3B (unresectable) Histologic evidence of non-small cell carcinoma Age > 18 years Karnofsky performance status 70 or greater No prior radiation to the chest No previous chemotherapy Exclusion Criteria: Clinical stage 1 or 4 Previous malignancies except for non-melanoma skin cancer unless disease free for > 3 years

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: Proton therapy with chemotherapy<br>Induction Chemotherapy - Two cycles Taxol 200mg/m2 and Carboplatin AUC6 on day 1 and day 22. Weekly chemotherapy concurrent with radiotherapy Taxol 50mg/m2 and Carboplatin AUC 2 weekly for 5 weeks. Proton therapy - 76 Gy in 5 weeks to lung tumor. | Radiation: Proton Radiation Therapy<br>* A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. The total dose given with proton beam is 76 Gy. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.<br>Drug: Taxol<br>* 200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.<br>* Other names: Paclitaxel;Drug: Carboplatin<br>* AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival. | Median survival time following treatment. | Monthly for duration of participant lifespan. Average lifespan 1-2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Related Toxicities. | grade 3 or higher esophageal toxicity Toxicity is categorized either early or late phase. Early phase- toxicity occurring during or within 30 days s/p treatment Late phase- toxicity occurring thereafter | Monthly for duration of participant lifespan. Average lifespan 1-2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proton, Radiation