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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Henning Willers, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01525446
First received: July 19, 2011
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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 Intervention
Non-small Cell Lung Cancer
Radiation: SBRT with proton beam radiation

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Feasibility and safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    To establish the feasibility and safety of fiducials placement by electromagnetic navigational bronchoscopy (ENB)

  • Safety and tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Frequency of radiation pneumonitis in participants treated with proton radiation


Secondary Outcome Measures:
  • Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Describe the acute and late toxicities of treatment using CTCAE v4.0

  • Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To describe radiological tumor responses

  • Disease Free survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To calculate local, regional, and distant failure rates

  • Overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To calculate the overall survival rate


Estimated Enrollment: 15
Study Start Date: September 2011
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525446

Contacts
Contact: Henning Willers, M.D. 617-726-5184 hwillers@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Henning Willers, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Henning Willers, M.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Henning Willers, M.D., Attending Radiation Oncologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01525446     History of Changes
Other Study ID Numbers: 11-021
Study First Received: July 19, 2011
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
NSCLC
Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014