Clinical trial NCT01525446: 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
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC
Lung Cancer
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-02-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility and safety
timeFrame: 2 years
measure: Safety and tolerability
timeFrame: 2 years
Secondary outcomes:
measure: Toxicity
timeFrame: 2 years
measure: Efficacy
timeFrame: 2 years
measure: Disease Free survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Henning Willers, M.D.
role: PRINCIPAL_INVESTIGATOR
References: