Stereotactic Radiosurgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00852644
• Other study ID #: H-26701
• Secondary ID: CDR0000635119
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Est. completion date: August 2016

Study information

• Verified date: April 2018
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: August 2016
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Procedure:
• computed tomography
Standard CT scans

Radiation:
• fludeoxyglucose F 18
standard doses with CT scans
• hypofractionated radiation therapy
4 doses over 2 weeks
• stereotactic radiosurgery
CyberKnife radiosurgery

Locations

Country	Name	City	State
United States	Boston University Cancer Research Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Who Did Not Experience a Dose Limiting Toxicity in the Less Than 3 Centimeter Cohort	Number of Participants Who Did Not Experience a Dose Limiting Toxicity in the less than 3 centimeter cohort	6 weeks
Primary	Maximum Tolerated Dose in the Less Than 3 Centimeter Cohort	The highest tolerable dose between 56 gray, 62 gray and 68 gray has not been established as the protocol was terminated early.	6 weeks
Primary	Participants Who Did Not Experience a Dose Limiting Toxicity in the More Than 3 Centimeter Cohort	The number of participants that did not experience a dose-limiting toxicity in the greater than 3 centimeter cohort	6 weeks
Primary	Maximum Tolerated Dose - More Than 3 Centimeter Cohort.	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	Relationship Between Positron Emission Tomography (PET) Response and Local Control and Survival	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