Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

Early Phase 1

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Radiation: SBRT with proton beam radiation

• Registration Number: NCT01525446
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Stereotactic body radiation therapy (SBRT) is a special form of treatment which pinpoints high doses of radiation directly to cancer. Standard radiation (or photon radiation) is commonly used for SBRT to treat Non-Small Cell Lung Cancer (NSCLC). Proton beam radiation is a special type of radiation only available at a few institutions in the US and has not been previously used in SBRT to treat NSCLC. The use of protons for SBRT may improve the accuracy of the treatment and may help to minimize the dose delivered unnecessarily to healthy tissue.

In this study, the investigators are evaluating the safety and effectiveness of proton-based SBRT for early-stage NSCLC located in the periphery of the lung.

Detailed Description

Subjects will undergo an electronic navigational bronchoscopy (ENB) during which three markers will be placed around their tumor which will guide the delivery of proton beam radiation to their with more precision and accuracy.

Subjects will receive a CT scan to obtain images to plan radiation treatment. Proton radiation will be delivered daily (4 or 5 consecutive days) on an outpatient basis at Massachusetts General Hospital.

After the final dose of proton radiation subjects will be followed for 5 years. Subjects will be asked to return at 3 months, and then every 3 months until 2 years, and then every 6 months until 5 years. Subjects will receive a chest CT, tumor assessment by CT or PET, chest x-ray, pulmonary function tests and a physical exam.

Study Timeline

• Study First Submitted: 2011-07-19
• Study Start: 2011-09
• Study First Submitted QC: 2012-01-31
• Study First Posted: 2012-02-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-12
• Last Update Posted: 2016-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• Histologically or cytologically confirmed non-small cell lung cancer (need not be newly diagnosed)
• Stage clinical T1 N0 M0 or T2 N0 M0
• NSCLC must be limited to a single lesion
• NSCLC must be peripherally located (> 2 cm from proximal bronchial tree and > 1 cm from mediastinal pleura)
• NSCLC must be considered medically inoperable
• Life expectancy greater than 6 months

Exclusion Criteria

• Pregnant or breastfeeding
• Prior radiation therapy to the lungs or mediastinum
• Prior malignancy in the last 2 years unless treated definitively and disease free or carcinoma in situ or early stage skin cancers that have been definitively treated
• Receiving other study agents or other types of cancer therapy
• Uncontrolled intercurrent illness
• Pacemaker or defibrillator-dependent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBRT with proton beam radiation	SBRT with proton beam radiation	4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of \> 3 cm)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	2 years	Frequency of radiation pneumonitis in participants treated with proton radiation
Feasibility and safety	2 years	To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)

Secondary Outcome Measures

Name	Time	Method
Toxicity	2 years	Describe the acute and late toxicities of treatment using CTCAE v4.0
Disease Free survival	2 years	To calculate local, regional, and distant failure rates
Efficacy	2 years	To describe radiological tumor responses
Overall survival	2 years	To calculate the overall survival rate

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States