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Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Hypofractionated, Image-Guided Radiation Therapy With Proton Therapy for Stage I Non-Small Cell Lung Cancer


Inclusion Criteria:



- Pathologically confirmed, by biopsy or cytology, non-small cell lung carcinoma
diagnosed within 3 months prior to study enrollment.

- T1, N0, M0 or T2, N0, M0.

- At least 18 years old at the time of consent.

- Adequate bone marrow function.

- Medically inoperable. Medically operable candidates are allowed if they refuse
surgical resection.

- If the patient has a large pleural effusion, it must be biopsy negative.

Exclusion Criteria:

- Evidence of distant metastasis (M1) and/or nodal involvement (N1, N2, N3).

- Synchronous primary.

- T2 tumors > 5 cm; T3, T4 primary tumor.

- Previous radiotherapy for lung cancer.

- Concomitant local, regional, and/or systemic therapy during radiotherapy.

- Active systemic, pulmonary, and/or pericardial infection.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.

Outcome Time Frame:

1 year after the end of radiation therapy

Safety Issue:

Yes

Principal Investigator

Bradford S Hoppe, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute

Authority:

United States: Institutional Review Board

Study ID:

UFPTI 0901 - LU03

NCT ID:

NCT00875901

Start Date:

September 2009

Completion Date:

April 2032

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Stage I Non-Small Cell Lung Cancer
  • Proton Radiation
  • HypoIGRT
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Florida Proton Therapy InstituteJacksonville, Florida  32206