Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
Phase 1
Terminated
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00614484
- Lead Sponsor
- Loma Linda University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Proton therapy with chemotherapy Proton Radiation Therapy 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. Proton therapy with chemotherapy Taxol 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. Proton therapy with chemotherapy Carboplatin 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.
- Primary Outcome Measures
Name Time Method Overall Survival. Monthly for duration of participant lifespan. Average lifespan 1-2 years Median survival time following treatment.
- Secondary Outcome Measures
Name Time Method Treatment Related Toxicities. Monthly for duration of participant lifespan. Average lifespan 1-2 years 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
Trial Locations
- Locations (1)
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
Loma Linda University Medical Center🇺🇸Loma Linda, California, United States