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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01525446
• Other study ID #: 11-021
• Status: Terminated
• Phase: Phase 0
• First received: July 19, 2011
• Last updated: February 12, 2016
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety	To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)	2 years	Yes
Primary	Safety and tolerability	Frequency of radiation pneumonitis in participants treated with proton radiation	2 years	Yes
Secondary	Toxicity	Describe the acute and late toxicities of treatment using CTCAE v4.0	2 years	Yes
Secondary	Efficacy	To describe radiological tumor responses	2 years	No
Secondary	Disease Free survival	To calculate local, regional, and distant failure rates	2 years	No
Secondary	Overall survival	To calculate the overall survival rate	2 years	No