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

This study has been completed.
Sponsor:
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00614484
First received: December 26, 2007
Last updated: June 29, 2011
Last verified: June 2011
  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.


Condition Intervention Phase
Locally Advanced Non-Small Cell Lung Cancer
Radiation: Proton Radiation Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate early and late toxicity of induction chemotherapy followed by high dose accelerated proton beam chemoradiotherapy. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 1999
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Proton Radiation Therapy
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00614484

Locations
United States, California
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: David A. Bush, MD Loma Linda University Department of Radiation Medicine
Study Chair: Jerry D. Slater, MD Loma Linda University Department of Radiation Medicine
  More Information

No publications provided

Responsible Party: David A. Bush, MD, Loma Linda University Department of Radiation Medicine
ClinicalTrials.gov Identifier: NCT00614484     History of Changes
Other Study ID Numbers: OSR #49168
Study First Received: December 26, 2007
Last Updated: June 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
Proton
Radiation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014