Know Cancer

or
forgot password

Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

Seamless Phase I/II Study of Stereotactic Lung Radiotherapy (SBRT) for Early Stage, Centrally Located, Non-Small Cell Lung Cancer (NSCLC) in Medically Inoperable Patients


OBJECTIVES:

Primary

- To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT)
in medically inoperable patients with centrally located stage I non-small cell lung
cancer. (Phase I)

- To determine the efficacy of SBRT when administered at the MTD in these patients.
(Phase I)

- To estimate the local control rate of SBRT at the MTD in these patients. (Phase II)

Secondary

- To estimate the rates of adverse events (other than dose-limiting toxicity) of ≥ grade
3 that is possibly, probably, or definitely related to treatment and that occurs within
1 year after the start of SBRT in these patients.

- To estimate the rates of late adverse events (i.e., occurs > 1 year after the start of
SBRT) in these patients.

- To estimate the local control and progression-free and overall survival rates in
patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo stereotactic body radiotherapy every 2 days over 1½-2 weeks (total of 5
fractions) in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

- Stage T1-2, N0, M0 disease

- Tumor size ≤ 5 cm

- Tumor must be 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 (i.e., 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) OR immediately adjacent to the
mediastinal or pericardial pleura (PTV touching the pleura)

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

- Mediastinal lymph node sampling by any technique is allowed but not
required

- Patients with > 1 cm hilar or mediastinal lymph nodes 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

- Tumor deemed technically resectable, in the opinion of an experienced thoracic cancer
surgeon, with a reasonable possibility of obtaining a gross total resection with
negative margins, defined as a potentially curative resection (PCR)

- Patient deemed "medically inoperable" due to severe underlying physiological medical
problems that would prohibit a PCR, 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 as documented by CT scan or whole-body PET scan within the past 8
weeks

- Patients with lesions that cannot be visualized by CT scan are not eligible

- Pleural effusion allowed provided it is deemed too small to tap under CT guidance and
is not evident on chest x-ray

- Pleural effusion that appears on chest x-ray is allowed only after thoracotomy
or other invasive procedure

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 60 days after
completion of study therapy

- No other invasive malignancy within the past 2 years except nonmelanomatous skin
cancer or carcinoma in situ of the breast, oral cavity, or cervix

- Prior lung cancer allowed provided the patient has been disease-free for ≥ 2
years

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy to the region of the study cancer that would result in overlap
of radiotherapy fields

- No prior chemotherapy for the study cancer

- No other concurrent local therapy (including standard-fractionated radiotherapy
and/or surgery) or systemic therapy (including standard chemotherapy or biologic
targeted agents) specifically intended as treatment for study cancer

- Local or systemic therapy at the time of disease progression allowed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose of stereotactic body radiotherapy (SBRT) as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0 (Phase I)

Outcome Time Frame:

From start of SBRT until 1 year.

Safety Issue:

Yes

Principal Investigator

Andrea Bezjak, MD, MSC, FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

United States: Federal Government

Study ID:

RTOG-0813

NCT ID:

NCT00750269

Start Date:

February 2009

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
University of California Davis Cancer CenterSacramento, California  95817
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
St. Luke's - Roosevelt Hospital Center - St.Luke's DivisionNew York, New York  10027
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
OSF St. Francis Medical CenterPeoria, Illinois  61637
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Frederick R. and Betty M. Smith Cancer Treatment CenterSparta, New Jersey  07871
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Flower Hospital Cancer CenterSylvania, Ohio  43560
Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
St. Joseph Cancer CenterBellingham, Washington  98225
Saint Louis University Cancer CenterSaint Louis, Missouri  63110
Sentara Cancer Institute at Sentara Norfolk General HospitalNorfolk, Virginia  23507
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Frankford Hospital Cancer Center - Torresdale CampusPhiladelphia, Pennsylvania  19114
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
CCOP - Kansas CityPrairie Village, Kansas  66208
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Arizona Center for Cancer Care - PeoriaPeoria, Arizona  85381
McLaren Cancer InstituteFlint, Michigan  48532
Norton Suburban HospitalLouisville, Kentucky  40207
Cooper CyberKnife CenterMount Laurel, New Jersey  08054