Expired Study
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Loma Linda, California 92354


Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

OSR #49168


NCT ID:

NCT00614484


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Loma Linda University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:David A. Bush, MD
Principal Investigator
Loma Linda University Department of Radiation Medicine

Study Dates

Start Date:August 1999
Completion Date:June 2011
Completion Type:Actual
Primary Completion Date:June 2011
Primary Completion Type:Actual
Verification Date:June 2011
Last Changed Date:June 29, 2011
First Received Date:December 26, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:To evaluate early and late toxicity of induction chemotherapy followed by high dose accelerated proton beam chemoradiotherapy.
Time Frame:Monthly
Safety Issues:True

Study Interventions

Intervention Type:Radiation
Name:Proton Radiation Therapy
Description:Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. 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. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Loma Linda University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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