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

This study has been terminated.
(Low participant enrollment rates. Significant comparative data not obtained.)
Sponsor:
Information provided by (Responsible Party):
Loma Linda University
ClinicalTrials.gov Identifier:
NCT00614484
First received: December 26, 2007
Last updated: April 28, 2014
Last verified: April 2014
  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
Drug: Taxol
Drug: Carboplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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:
  • Overall Survival. [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ] [ Designated as safety issue: Yes ]
    Median survival time following treatment.


Secondary Outcome Measures:
  • Treatment Related Toxicities. [ Time Frame: Monthly for duration of participant lifespan. Average lifespan 1-2 years ] [ Designated as safety issue: Yes ]

    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



Enrollment: 28
Study Start Date: August 1999
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Loma Linda University
ClinicalTrials.gov Identifier: NCT00614484     History of Changes
Other Study ID Numbers: OSR #49168
Study First Received: December 26, 2007
Results First Received: July 16, 2013
Last Updated: April 28, 2014
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
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014