Back to resultsChemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
Primary Purpose
Locally Advanced Non-Small Cell Lung Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Proton Radiation Therapy
Taxol
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Non-Small Cell Lung Cancer focused on measuring Proton, Radiation
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
Sites / Locations
- Loma Linda University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Proton therapy with chemotherapy
Arm 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.
Outcomes
Primary Outcome Measures
Overall Survival.
Median survival time following treatment.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00614484
First Posted
December 26, 2007
Last Updated
April 28, 2014
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT00614484
Brief Title
Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Low participant enrollment rates. Significant comparative data not obtained.
Study Start Date
August 1999 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Non-Small Cell Lung Cancer
Keywords
Proton, Radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Proton therapy with chemotherapy
Arm Type
Experimental
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Proton Radiation Therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Taxol
Other Intervention Name(s)
Paclitaxel
Intervention Description
200 mg/m2, IV, for 2 cycles followed by 50 mg/m2 weekly for 5 weeks during radiotherapy.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
AUC 6, IV, for two cycles followed by AUC 2 weekly for 5 weeks during radiotherapy.
Primary Outcome Measure Information:
Title
Overall Survival.
Description
Median survival time following treatment.
Time Frame
Monthly for duration of participant lifespan. Average lifespan 1-2 years
Secondary Outcome Measure Information:
Title
Treatment Related Toxicities.
Description
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
Time Frame
Monthly for duration of participant lifespan. Average lifespan 1-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David A. Bush, MD
Organizational Affiliation
Loma Linda University Department of Radiation Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jerry D. Slater, MD
Organizational Affiliation
Loma Linda University Department of Radiation Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
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