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Trial record 1 of 1 for:    NCT01525446
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Proton Stereotactic Body Radiation Therapy for Early-Stage Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01525446
Recruitment Status : Terminated (Slow accrual)
First Posted : February 3, 2012
Last Update Posted : February 17, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Henning Willers, M.D., Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Radiation: SBRT with proton beam radiation Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Stereotactic Body Radiation Therapy (SBRT) for Medically Inoperable, Peripheral Early-Stage Non-Small Cell Lung Cancer (NSCLC): A Pilot Study
Study Start Date : September 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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)
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)

Primary Outcome Measures :
  1. Feasibility and safety [ Time Frame: 2 years ]
    To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)

  2. Safety and tolerability [ Time Frame: 2 years ]
    Frequency of radiation pneumonitis in participants treated with proton radiation

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 2 years ]
    Describe the acute and late toxicities of treatment using CTCAE v4.0

  2. Efficacy [ Time Frame: 2 years ]
    To describe radiological tumor responses

  3. Disease Free survival [ Time Frame: 2 years ]
    To calculate local, regional, and distant failure rates

  4. Overall survival [ Time Frame: 2 years ]
    To calculate the overall survival rate

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01525446

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
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Principal Investigator: Henning Willers, M.D. Massachusetts General Hospital
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Responsible Party: Henning Willers, M.D., Attending Radiation Oncologist, Massachusetts General Hospital Identifier: NCT01525446    
Other Study ID Numbers: 11-021
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Keywords provided by Henning Willers, M.D., Massachusetts General Hospital:
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms