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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Locally Advanced Non-Small Cell Lung Cancer

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Trial Information

Phase I/II Study of Combined Chemotherapy and High Dose, Accelerated Proton Radiation for the Treatment of Locally Advanced Non-Small Cell Lung Carcinoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

Monthly

Safety Issue:

Yes

Principal Investigator

David A. Bush, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Department of Radiation Medicine

Authority:

United States: Institutional Review Board

Study ID:

OSR #49168

NCT ID:

NCT00614484

Start Date:

August 1999

Completion Date:

June 2011

Related Keywords:

  • Locally Advanced Non-Small Cell Lung Cancer
  • Proton
  • Radiation
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Loma Linda University Medical CenterLoma Linda, California  92354