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


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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 6 weeks, 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.


Inclusion Criteria:



- Histologically or cytologically confirmed non-small cell lung cancer

- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility and safety

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Henning Willers, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

11-021

NCT ID:

NCT01525446

Start Date:

September 2011

Completion Date:

Related Keywords:

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

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617