Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with stage I or stage II non-small cell lung cancer.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- To establish the maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery in patients with medically inoperable, stage I or II non-small cell lung cancer.
- To establish the relationship between positron emission tomography (PET) response and local control and survival using fludeoxyglucose F 18 PET/CT imaging before treatment and at 1, 3, 6, and 12 months after treatment.
OUTLINE: Patients undergo placement of 3 gold fiducial markers by CT-guidance or bronchoscopy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 45-120 minutes twice weekly for 2 weeks.
Patients undergo fludeoxyglucose F 18 PET/CT scan at baseline and at 1, 3, 6, and 12 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 4 years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02118
- Boston University Cancer Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Stage I or II disease (T1-3, N0, M0)
- T2 or T3 tumor ≤ 5 cm
- No T3 tumors involving the central chest or mediastinum (only chest wall involvement allowed)
Tumor deemed technically resectable, in the opinion of an experienced thoracic surgeon, AND patient deemed "medically inoperable"
- Patients with fluorodeoxyglucose (FDG)-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
Exclusion Criteria:
- No history of contrast allergy
- No psychological issues that would preclude the completion of study treatment
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy or chemotherapy
- No suspected nodal metastasis that cannot be falsified by mediastinoscopy (i.e., hilar or mediastinal nodes that are either fludeoxyglucose F 18 [FDG]-avid or measure > 1 cm in short axis diameter on CT scan)
- No tumor within or touching the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main stem bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 56 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 62 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 68 Gray (LESS than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 56 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 56 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 62 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 62 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
|
Experimental: 68 Gray (MORE than 3 centimeter cohort)
Intervention: Procedure/Surgery: computed tomography Standard CT scans Intervention: Radiation: fludeoxyglucose F 18 standard doses with CT scans Radiation: hypofractionated radiation therapy 4 doses over 2 weeks - 68 Gray Radiation: stereotactic radiosurgery CyberKnife radiosurgery |
Standard CT scans
standard doses with CT scans
4 doses over 2 weeks
CyberKnife radiosurgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort
Time Frame: 6 weeks
|
Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort
Time Frame: 6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
|
Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort
Time Frame: 6 weeks
|
The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort
|
6 weeks
|
|
Maximum Tolerated Dose - More Than 3 Centimeter Cohort.
Time Frame: 6 weeks
|
The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival
Time Frame: before treatment and at 1, 3, 6, and 12 months after treatment
|
Relationship between positron emission tomography (PET) response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
|
before treatment and at 1, 3, 6, and 12 months after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Minh Tam Truong, MD, Boston Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-26701
- CDR0000635119 (Other Grant/Funding Number: Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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