Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments computed tomography, fludeoxyglucose f 18, hypofractionated radiation therapy, stereotactic radiosurgery
Phase phase 1
Sponsor Boston Medical Center
Collaborator United States Department of Defense
Start date January 2009
End date June 2013
Trial size 36 participants
Trial identifier NCT00852644, BUMC-H-26701, CDR0000635119

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Radiation: stereotactic radiosurgery CyberKnife radiosurgery
computed tomography
Standard CT scans
fludeoxyglucose f 18
standard doses with CT scans
hypofractionated radiation therapy
4 doses over 2 weeks
stereotactic radiosurgery
CyberKnife radiosurgery

Primary Outcomes

Measure
To establish the maximally tolerated dose of CyberKnife® radiosurgery in patients with medically inoperable clinical Tl-3 N0 M0 NSCLC
time frame: 6 weeks

Secondary Outcomes

Measure
Relationship between PET response and local control and survival as measured by fludeoxyglucose F 18 PET/CT imaging
time frame: before treatment and at 1, 3, 6, and 12 months after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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 FDG-avidity in mediastinal lymph nodes are eligible provided they are able to undergo mediastinoscopy to confirm N0 status PATIENT CHARACTERISTICS: - 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)

Additional Information

Official title Feasibility and Outcome of Cyberknife® Precision Hypofractionated Radiosurgery for the Curative Management of Non-Small Cell Lung Cancer
Principal investigator Lisa A. Kachnic, MD
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Boston Medical Center.