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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00614484 |
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Date of registration:
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26/12/2007 |
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Primary sponsor: |
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Public title:
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Chemotherapy and Proton Radiation for the Treatment of Locally Advanced Lung Cancer
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Scientific title:
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Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma |
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Date of first enrolment:
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August 1999 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00614484 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David A. Bush, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Loma Linda University Department of Radiation Medicine |
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Name:
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Jerry D. Slater, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Loma Linda University Department of Radiation Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical stage II, IIIA or IIIB (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
- FEV1 > 1.0 liters
- No malignant pleural effusion
- WBC > 3500, platelets > 100,000, Hgb > 10.0.
- Serum creatinine < 1.5, bilirubin < 1.5, Ca++ WNL, alk phos, AST, ALT < 2X upper
limit.
Exclusion Criteria:
- Clinical stage I or IV
- Previous malignancies except for non-melanoma skin cancer unless disease free for > 3
years
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Locally Advanced Non-Small Cell Lung Cancer
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Intervention(s)
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Radiation: Proton Radiation Therapy
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Primary Outcome(s)
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To define the local control, overall survival, disease free survival, and pattern of relapse of patients receiving induction chemotherapy followed by chemoradiotherapy with proton beam.
[Time Frame: Monthly]
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Secondary Outcome(s)
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To evaluate early and late toxicity of induction chemotherapy followed by high dose accelerated proton beam chemoradiotherapy.
[Time Frame: Monthly]
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Secondary ID(s)
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OSR #49168
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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