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A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

A Randomized Phase II Study Comparing 2 Stereotactic Body Radiation Therapy (SBRT) Schedules for Medically Inoperable Patients With Stage I Peripheral Non-Small Cell Lung Cancer


OBJECTIVES:

Primary

- To determine the 1-year rate of ≥ grade 3 adverse events that are definitely, probably,
or possibly related to treatment with single fraction vs multiple fraction stereotactic
body radiotherapy in medically inoperable patients with stage I peripheral non-small
cell lung cancer.

Secondary

- To estimate the 1-year primary tumor control rate in these patients.

- To estimate the 1-year overall survival and disease-free survival rate of these
patients.

- To assess FDG-PET standardized uptake value changes as a measure of treatment response
and outcomes.

- To determine pulmonary function changes by treatment arm and response.

- To determine the association between biomarkers and primary tumor control and/or ≥
grade 2 radiation pneumonitis.

OUTLINE: This is a multicenter study. Patients are stratified according to Zubrod
performance status (0 vs 1 vs 2) and T stage (T1 vs T2). Patients are randomized to 1 of 2
treatment arms.

- Arm I (single fraction): Patients undergo one stereotactic body radiotherapy (SBRT)
treatment to the target lesion.

- Arm II (multiple fractions): Patients undergo SBRT to the target lesion once daily for
4 days.

Blood and tumor tissue samples may be collected for further analysis.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary non-small cell lung cancer,
including one of the following subtypes:

- Squamous cell carcinoma

- Adenocarcinoma

- Large cell carcinoma

- Large cell neuroendocrine carcinoma

- Non-small cell carcinoma not otherwise specified

- Stage T1-2, N0, M0 disease

- Tumor size ≤ 5 cm

- Hilar or mediastinal lymph nodes ≤ 1 cm with no abnormal hilar or mediastinal
uptake on PET scan are considered N0

- Patients with hilar or mediastinal lymph nodes > 1 cm on CT scan or
abnormal PET scan (including suspicious but nondiagnostic uptake) are
eligible provided directed tissue biopsies of all abnormally identified
areas are negative for cancer

- No regional or distant metastases

- Peripherally located tumor

- No primary tumor within or touching the zone of the proximal bronchial tree,
defined as a volume of 2 cm in all directions around the proximal bronchial tree
(carina, right and left main bronchi, right and left upper lobe bronchi,
intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and
left lower lobe bronchi)

- No involvement of the central pleura and/or structures of the mediastinum

- Resectable disease

- Patient may have declined surgery after consulting with a thoracic surgeon

- Patient deemed "medically inoperable", in the opinion of an experienced thoracic
cancer clinician (thoracic surgeon, medical oncologist, radiation oncologist, or
pulmonologist), due to a severe underlying physiological medical problem that would
preclude surgery, including any of the following:

- Baseline forced expiratory volume at one second (FEV1) < 40% predicted

- Postoperative FEV1 < 30% predicted

- Severely reduced diffusion capacity

- Baseline hypoxemia and/or hypercapnia

- Exercise oxygen consumption < 50% predicted

- Severe pulmonary hypertension

- Diabetes mellitus with severe end-stage organ damage

- Severe cerebral, cardiac, or peripheral vascular disease

- Severe chronic heart disease

- Measurable disease

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Absolute neutrophil count (ANC) ≥ 1,800/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No synchronous primary malignancy or other malignancy within the past 2 years except
for any of the following:

- Invasive malignancy that was definitively treated and patient remains disease
free for > 3 years with a life expectancy of > 3 years

- Carcinoma in situ

- Early stage skin cancer that was definitively treated

- No active systemic, pulmonary, or pericardial infection

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to the lung or mediastinum

- No prior chemotherapy for this lung or mediastinal tumor

- Prior chemotherapy for another invasive malignancy allowed provided it was
definitively treated and patient remains disease free for > 3 years

- No prior surgery for this lung or mediastinal tumor

- No other concurrent antineoplastic therapy, including standard fractionated
radiotherapy, chemotherapy, biological therapy, vaccine therapy, and/or surgery

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

1-year rate of ≥ grade 3 adverse events that are definitely, probably, or possibly related to treatment

Outcome Time Frame:

From start of treatment to 1 year

Safety Issue:

Yes

Principal Investigator

Gregory Videtic, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000652101

NCT ID:

NCT00960999

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • squamous cell lung cancer
  • adenocarcinoma of the lung
  • large cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
CCOP - Kansas CityKansas City, Missouri  64131
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Memorial Hospital of South BendSouth Bend, Indiana  46601
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Community Cancer CenterNormal, Illinois  61761
OSF St. Francis Medical CenterPeoria, Illinois  61637
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Great Lakes Cancer Institute at McLaren Regional Medical CenterFlint, Michigan  48532
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Flower Hospital Cancer CenterSylvania, Ohio  43560
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Inova Alexandria HospitalAlexandria, Virginia  22304
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608