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

Loma Linda University1 site in 1 country28 target enrollmentAugust 1999

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 1999

End Date

June 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Loma Linda University

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: Proton Radiation Therapy

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.

Intervention: Taxol

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.

Intervention: Carboplatin