Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00614484|
Recruitment Status : Terminated (Low participant enrollment rates. Significant comparative data not obtained.)
First Posted : February 13, 2008
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Non-Small Cell Lung Cancer||Radiation: Proton Radiation Therapy Drug: Taxol Drug: Carboplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||August 1999|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|