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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

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)

- 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)

- Tumor deemed technically resectable, in the opinion of an experienced thoracic
surgeon, AND patient deemed "medically inoperable"

- 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)

- 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

- No history of contrast allergy

- No psychological issues that would preclude the completion of study treatment

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy or chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To establish the maximally tolerated dose of CyberKnife® radiosurgery in patients with medically inoperable clinical Tl-3 N0 M0 NSCLC

Outcome Time Frame:

6 weeks

Safety Issue:

No

Principal Investigator

Lisa A. Kachnic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Boston Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000635119

NCT ID:

NCT00852644

Start Date:

January 2009

Completion Date:

March 2014

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Boston University Cancer Research CenterBoston, Massachusetts  02118