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

Primary Purpose

Non-small Cell Lung Cancer

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

SBRT with proton beam radiation

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring NSCLC, Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SBRT with proton beam radiation

Arm Description

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)

Outcomes

Primary Outcome Measures

Feasibility and safety

To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)

Safety and tolerability

Frequency of radiation pneumonitis in participants treated with proton radiation

Secondary Outcome Measures

Toxicity

Describe the acute and late toxicities of treatment using CTCAE v4.0

Efficacy

To describe radiological tumor responses

Disease Free survival

To calculate local, regional, and distant failure rates

Overall survival

To calculate the overall survival rate

Full Information

NCT ID

NCT01525446

First Posted

July 19, 2011

Last Updated

February 12, 2016

Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01525446

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

September 2011 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

Keywords

NSCLC, Lung Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SBRT with proton beam radiation

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

SBRT with proton beam radiation

Intervention Description

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 Measure Information:

Title

Feasibility and safety

Description

To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)

Time Frame

2 years

Title

Safety and tolerability

Description

Frequency of radiation pneumonitis in participants treated with proton radiation

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Toxicity

Description

Describe the acute and late toxicities of treatment using CTCAE v4.0

Time Frame

2 years

Title

Efficacy

Description

To describe radiological tumor responses

Time Frame

2 years

Title

Disease Free survival

Description

To calculate local, regional, and distant failure rates

Time Frame

2 years

Title

Overall survival

Description

To calculate the overall survival rate

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henning Willers, M.D.

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02214

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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