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Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)


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

Thank you

Trial Information

Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)


OBJECTIVES:

Primary

- To compare the 1-year overall median survival rate in patients with extensive stage
small cell lung cancer treated with prophylactic cranial irradiation with vs without
consolidative extracranial radiotherapy following platinum-based chemotherapy.

Secondary

- To compare treatment-related adverse events in these patients.

- To evaluate patterns of failure in these patients.

- To compare the time to first failure in these patients.

- To evaluate the percentage of the planned radiotherapy dose given to each site.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
treatment (complete response vs partial response) and number of metastatic lesions (1 vs
2-3). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.

- Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also
undergo consolidative extracranial radiotherapy to locoregional and residual metastatic
disease 5 days per week for 2-3 weeks.

After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and
12 months; every 6 months for 2 years; and then annually thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed extensive stage small cell lung cancer
(SCLC) diagnosed within the past 6 months*

- Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment
with chemotherapy

- Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND
meets the following criteria:

- Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease
according to RECIST criteria (if radiotherapy has been delivered to primary
disease with chemotherapy, there must be complete or partial response in ≥ 1 of
the sites that has not been treated with radiotherapy)

- No progression in any site

- No limited stage SCLC, even if disease progressed

- No brain or CNS metastases

PATIENT CHARACTERISTICS:

- Zubrod performance status 0-2

- ANC ≥ 1,000/mm^3

- Platelets ≥ 75,000/mm^3

- Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)

- Serum ALT and AST ≤ 2.5 times upper limit of normal (ULN) (for patients who will
receive radiotherapy to the liver)

- Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the
liver)

- Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the
kidneys)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No severe, active co-morbidity, defined as any of the following:

- Acute bacterial or fungal infection requiring IV antibiotics at the time of
study registration

- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of study
registration

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy
and alopecia])

- Thoracic radiotherapy administered concurrently with or before chemotherapy for the
current diagnosis allowed (these patients will not receive mediastinal radiotherapy
per protocol)

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

- No concurrent chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Elizabeth M. Gore, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin

Authority:

Unspecified

Study ID:

CDR0000663959

NCT ID:

NCT01055197

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
St. John Macomb HospitalWarren, Michigan  48093
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
University of Texas Medical BranchGalveston, Texas  77555-1329
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
James Graham Brown Cancer Center at University of LouisvilleLouisville, Kentucky  40202
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Parma Community General HospitalParma, Ohio  44129
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Highland Hospital of RochesterRochester, New York  14620
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Cleveland Clinic - WoosterWooster, Ohio  44691
Poudre Valley Radiation OncologyFort Collins, Colorado  80528
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Frederick R. and Betty M. Smith Cancer Treatment CenterSparta, New Jersey  07871
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
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
St. Anne Mercy HospitalToledo, Ohio  43623
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Elliot Regional Cancer Center at Elliot HospitalManchester, New Hampshire  03103
Three Rivers Community HospitalGrants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical CenterMedford, Oregon  97504
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Tyler Cancer CenterTyler, Texas  75702
Boston University Cancer Research CenterBoston, Massachusetts  02118
Trinity CancerCare CenterMinot, North Dakota  58701
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
Cancer Institute of Cape Girardeau, LLCCape Girardeau, Missouri  63703
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Integrated Community Oncology Network - Orange ParkOrange Park, Florida  32073
Georgia Cancer Center for Excellence at Grady Memorial HospitalAtlanta, Georgia  30303
Emory Crawford Long HospitalAtlanta, Georgia  30308
New York Oncology Hematology, PC at Albany Regional Cancer CareAlbany, New York  12208
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Barnes-Jewish West County HospitalSaint Louis, Missouri  63141
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Community Regional Cancer Care at Community Hospital NorthIndianapolis, Indiana  46256
Community Regional Cancer Care at Community Hospital EastIndianapolis, Indiana  46219
Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida  32207
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
UHHS Westlake Medical CenterWestlaker, Ohio  44145
Kansas City Cancer Centers - SouthwestOverland Park, Kansas  66210
Longview Cancer CenterLongview, Texas  75601
Riverview UW Cancer Center at Riverview HospitalWisconsin Rapids, Wisconsin  54494
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
Radiation Oncology Associates SouthwestFort Wayne, Indiana  46804
Henry Ford Macomb HospitalClinton Township, Michigan  48038
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Texas Oncology, PA at Texas Cancer Center - Denton SouthDenton, Texas  76210
Klabzuba Cancer Center at Harris Methodist Fort Worth HospitalFort Worth, Texas  76104
Cancer Care Centers of South Texas - NortheastSan Antonio, Texas  78217
Texas Oncology, PA at Texas Cancer Center - ShermanSherman, Texas  75090
Texas Oncology, PA at Texas Oncology Cancer Center Sugar LandSugar Land, Texas  77479
Nebraska Medical CenterOmaha, Nebraska  68198
Arizona Oncology - TucsonTucson, Arizona  85704
Kansas City Cancer Centers - SouthKansas City, Missouri  64131
Saint Agnes Cancer Center at Saint Agnes Medical CenterFresno, California  93720
Texas Oncology, PA at Texas Cancer Center - Arlington SouthArlington, Texas  76014
Memorial Hermann Hospital - Memorial CityHouston, Texas  77024
Texas Oncology, PA - Wichita FallsWichita Falls, Texas  76310