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

Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: SBRT with proton beam radiation

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02214
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Henning Willers, M.D., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 19, 2011
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 3, 2012

Study Record Updates

• Last Update Posted (Estimate): February 17, 2016
• Last Update Submitted That Met QC Criteria: February 12, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Lung Cancer; NSCLC
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 11-021