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

Not Applicable

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Radiation: Peripherally located lung tumor; Radiation: Centrally located lung tumor

• 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

Arm && Interventions

Group	Intervention	Description
Peripherally located lung tumor	Peripherally located lung tumor	12 cobalt gray equivalent per fraction to a total of 48 cobalt gray equivalent
Centrally located lung tumor	Centrally located lung tumor	6 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent

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
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
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

Trial Locations

Locations (1)

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