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

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ClinicalTrials.gov Identifier: NCT00614484
Recruitment Status : Terminated (Low participant enrollment rates. Significant comparative data not obtained.)
First Posted : February 13, 2008
Results First Posted : May 22, 2014
Last Update Posted : May 22, 2014
Sponsor:
Information provided by (Responsible Party):
Loma Linda University

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.

Condition or disease Intervention/treatment Phase
Locally Advanced Non-Small Cell Lung Cancer Radiation: Proton Radiation Therapy Drug: Taxol Drug: Carboplatin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 1999
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Proton therapy with chemotherapy

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.

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 Name: Paclitaxel

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




Primary Outcome Measures :
  1. Overall Survival. [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ]
    Median survival time following treatment.


Secondary Outcome Measures :
  1. Treatment Related Toxicities. [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ]

    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




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT00614484     History of Changes
Other Study ID Numbers: OSR #49168
First Posted: February 13, 2008    Key Record Dates
Results First Posted: May 22, 2014
Last Update Posted: May 22, 2014
Last Verified: April 2014

Keywords provided by Loma Linda University:
Proton
Radiation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Paclitaxel
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action