Trial | NCT00614484  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Study Participants

    28
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.
Study Started
Aug 31
1999
Primary Completion
Jun 30
2011
Study Completion
Jun 30
2011
Results Posted
May 22
2014
Estimate
Last Update
May 22
2014
Estimate

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 names: Paclitaxel

Drug Carboplatin

AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.

Proton therapy with chemotherapy Experimental

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.

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

Summary

Treatment With Chemotherapy and Proton Beam Radiotherapy.

All Events

Event Type Organ System Event Term Treatment With Chemotherapy and Proton Beam Radiotherapy.

Overall Survival.

Median survival time following treatment.

Chemothrapy and Proton Therapy

15.0
Months (Median)
95% Confidence Interval: 10.0 to 20.0

Treatment Related Toxicities.

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

Chemotherapy and Proton Therapy

2.0
participants

Age, Continuous

66
years (Mean)
Standard Deviation: 8

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Treatment With Chemotherapy and Proton Beam Radiotherapy.