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

NCT ID: NCT01525446

Last Updated: 2016-02-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2015-12-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

SBRT with proton beam radiation

Intervention Type: 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)

Interventions

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)

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henning Willers, M.D.

Attending Radiation Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henning Willers, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

11-021

Identifier Type: -

Identifier Source: org_study_id