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A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer


Phase 2/Phase 3
N/A
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer


OBJECTIVES:

- Compare the incidence of brain metastases in patients with limited stage small cell
lung cancer treated with different regimens of prophylactic cranial irradiation. (phase
III closed to accrual as of 12/31/05)

- Compare the overall and disease-free survival of patients treated with these regimens.
(phase III closed to accrual as of 12/31/05)

- Compare the incidence of chronic neurotoxicity in patients treated with these regimens.

- Compare quality of life and late treatment sequelae of patients treated with these
regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
(60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days
vs 181-240 days). Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a
week. Treatment continues for 2 weeks in the absence of unacceptable toxicity.

- Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6
weeks in the absence of unacceptable toxicity.

- Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4
weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3
years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed small cell lung cancer by fine needle
aspiration, biopsy, or 2 positive sputa

- Limited stage (I-IIIB)

- Confined to 1 hemithorax

- No T4 or N3 disease

- Complete response after induction chemotherapy (with or without thoracic
radiotherapy)

- Consolidative chest radiotherapy may be initiated before study

- No radiographic evidence of any of the following:

- Brain metastases

- Normal brain CT scan or MRI less than 1 month before study

- Ipsilateral lung metastases

- Malignant pleural effusion

- Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

Age

- Not specified

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 75,000/mm^3

- Hemoglobin at least 10.0 g/dL^

Hepatic

- Not specified

Renal

- Not specified

Pulmonary

- See Disease Characteristics

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Neurological function class 1 or 2

- No epilepsy requiring permanent oral medication

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No other serious medical or psychiatric condition that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- At least 1 week since prior chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- No prior external beam radiotherapy to the head or neck, including stereotactic
radiotherapy

- Concurrent thoracic radiotherapy allowed

Surgery

- Not specified

Other

- No concurrent antitumor agents

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Incidence of brain metastases (Phase III patients enrolled before 12/31/05)

Safety Issue:

No

Principal Investigator

Aaron H. Wolfson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000258668

NCT ID:

NCT00057746

Start Date:

February 2003

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
St. Rita's Medical CenterLima, Ohio  45801
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Northwest Community HospitalArlington Heights, Illinois  60005
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Veterans Affairs Medical Center - Ann ArborAnn Arbor, Michigan  48105
John F. Kennedy Medical CenterEdison, New Jersey  08818
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - GreenvilleGreenville, South Carolina  29615
LDS HospitalSalt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Wesley Medical CenterWichita, Kansas  67214
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Cottonwood Hospital Medical CenterMurray, Utah  84107
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Mecosta County Medical CenterBig Rapids, Michigan  49307
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Booker Cancer Center at Riverview Medical CenterRed Bank, New Jersey  07701
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Highland Hospital of RochesterRochester, New York  14620
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Iredell Memorial HospitalStatesville, North Carolina  28677
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
St. Anthony's Memorial HospitalEffingham, Illinois  62401
Northeast Georgia Medical CenterGainesville, Georgia  30501
Cancer Center at Ball Memorial HospitalMuncie, Indiana  47303
South Suburban Oncology CenterQuincy, Massachusetts  02169
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Huron Hospital Cancer Care CenterCleveland, Ohio  44112
Euclid HospitalCleveland, Ohio  44119
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
South Pointe Hospital Cancer Care CenterWarrensville Heights, Ohio  44122
Cancer Treatment CenterWooster, Ohio  44691
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Frederick R. and Betty M. Smith Cancer Treatment CenterSparta, New Jersey  07871
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Flower Hospital Cancer CenterSylvania, Ohio  43560
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
Fox Chase Cancer Center CCOP Research BasePhiladelphia, Pennsylvania  19140
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California  91767
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Parkview Regional Cancer Center at Parkview HealthFort Wayne, Indiana  46805
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Three Rivers Community HospitalGrants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical CenterMedford, Oregon  97504
Regional Cancer Center at Oconomowoc Memorial HospitalOconomowoc, Wisconsin  53066
Kinston Medical SpecialistsKinston, North Carolina  28501
MedCentral - Mansfield HospitalMansfield, Ohio  44903
Highlands Oncology Group - SpringdaleSpringdale, Arkansas  72764
La Grange Memorial HospitalLa Grange, Illinois  60525
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Solano Radiation Oncology CenterVacaville, California  95687
Franklin & Edith Scarpa Regional Cancer Center at South Jersey HealthcareVineland, New Jersey  08360
Galesburg Clinic, PCGalesburg, Illinois  61401
Boston University Cancer Research CenterBoston, Massachusetts  02118
Mercy General HospitalSacramento, California  95819
Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260
Virginia G. Piper Cancer Center at Scottsdale Healthcare - OsbornScottsdale, Arizona  85251
Veterans Affairs Medical Center - IndianapolisIndianapolis, Indiana  46202
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
Bay MedicalPanama City, Florida  32401
Cancer Institute of Cape Girardeau, LLCCape Girardeau, Missouri  63703
Ocean Medical Center at Meridian HealthBrick, New Jersey  08724
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Providence Cancer Center at PMCCMedford, Oregon  97504
Veterans Affairs Medical Center - MilwaukeeMilwaukee, Wisconsin  53295
Memorial Hospital Cancer Center - Colorado SpringsColorado Springs, Colorado  80909
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Immanuel St. Joseph'sMankato, Minnesota  56002
Arlington Cancer Center - ArlingtonArlington, Texas  76012
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
Radiation Oncology Associates - RenoReno, Nevada  89509
Hudson Valley Oncology AssociatesPoughkeepsie, New York  12601
Harrison Medical CenterBremerton, Washington  98310