Proton Therapy for Stage I Non-Small Cell Lung Cancer (LU03)

Not Applicable

Completed

• Conditions: Non-Small Cell Lung Cancer

• Registration Number: NCT00875901
• Lead Sponsor: University of Florida

Brief Summary

This is a research study to determine if hypofractionated image guided radiation therapy (hypoIGRT) with proton therapy is a good way to treat early stage lung tumors for patients who will not have surgery. HypoIGRT delivers higher daily doses of radiation over a shorter period of time compared with conventional radiation. This is thought to deliver a more lethal dose of radiation to the tumor and is more convenient with treatment being completed within 2-3 weeks compared to the typical 7-8 week course of conventional radiotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-02
• Study First Submitted QC: 2009-04-03
• Study First Posted: 2009-04-06
• Study Start: 2009-09
• Status Verified: 2022-03
• Primary Completion: 2022-03-21
• Study Completion: 2022-03-21
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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. (AJCC Lung 7th Edition)
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Confirm Grade 3 or higher toxicity rate of hypoIGRT proton therapy in patients with stage I non-small cell lung cancer.	1 year after the end of radiation therapy

Secondary Outcome Measures

Name	Time	Method
Assess differences in dosimetric values compared with photons for lung, heart, esophagus, spinal cord, skin and brachial plexus	When each patient has been followed for a minimum of 12 months to a maximum of 5 years
Assess changes in quality of life before and after treatment	Before treatment and then when each patient has been followed for a minimum of 12 months to a maxiumum of 5 years
Collect and analyze outcome data on tumor control and survival	When each patient has been followed for a minimum of 12 months to a maximum of 5 years

Trial Locations

Locations (1)

University of Florida Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States