Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
|Locally Advanced Non-Small Cell Lung Cancer||Radiation: Proton Radiation Therapy Drug: Taxol Drug: Carboplatin||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma|
- Overall Survival. [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ]Median survival time following treatment.
- Treatment Related Toxicities. [ Time Frame: 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
|Study Start Date:||August 1999|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Experimental: Proton therapy with chemotherapy
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
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.Drug: Taxol
200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
Other Name: PaclitaxelDrug: Carboplatin
AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614484
|United States, California|
|Loma Linda University Medical Center|
|Loma Linda, California, United States, 92354|
|Principal Investigator:||David A. Bush, MD||Loma Linda University Department of Radiation Medicine|
|Study Chair:||Jerry D. Slater, MD||Loma Linda University Department of Radiation Medicine|