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

Loma Linda University (LLU)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Locally Advanced Non-Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Taxol; Radiation: Proton Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00614484

OSR #49168

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Proton therapy with chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Carboplatin

Drug: Taxol

Radiation: Proton Radiation Therapy