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

Phase 1

Terminated

• Conditions: Locally Advanced Non-Small Cell Lung Cancer
• Interventions: Radiation: Proton Radiation Therapy; Drug: Taxol; Drug: Carboplatin

• 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

Study Timeline

• Study Start: 1999-08
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-13
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-07-16
• Status Verified: 2014-04
• Results First Submitted QC: 2014-04-28
• Last Update Submitted: 2014-04-28
• Results First Posted: 2014-05-22
• Last Update Posted: 2014-05-22

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