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

Mass General Brigham

Status and phase

Terminated

Early Phase 1

Conditions

Non-small Cell Lung Cancer

Treatments

Radiation: SBRT with proton beam radiation

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01525446

11-021

Details and patient eligibility

About

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.

Full 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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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