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
N/A
N/A
Not Enrolling
Both
Lung Cancer
Both
Lung Cancer
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 Institute | Buffalo, New York 14263 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Aultman Cancer Center at Aultman Hospital | Canton, Ohio 44710-1799 |
| St. Rita's Medical Center | Lima, Ohio 45801 |
| Penn State Cancer Institute at Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse, Wisconsin 54601 |
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Northwest Community Hospital | Arlington Heights, Illinois 60005 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| Veterans Affairs Medical Center - Ann Arbor | Ann Arbor, Michigan 48105 |
| John F. Kennedy Medical Center | Edison, New Jersey 08818 |
| Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Waukesha Memorial Hospital Regional Cancer Center | Waukesha, Wisconsin 53188 |
| University of Florida Shands Cancer Center | Gainesville, Florida 32610-0232 |
| Baptist-South Miami Regional Cancer Program | Miami, Florida 33176 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Presbyterian Cancer Center at Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| Hollings Cancer Center at Medical University of South Carolina | Charleston, South Carolina 29425 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Bay Area Cancer Care Center at Bay Area Medical Center | Marinette, Wisconsin 54143 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Holland Community Hospital | Holland, Michigan 49423 |
| Hackley Hospital | Muskegon, Michigan 49443 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Cottonwood Hospital Medical Center | Murray, Utah 84107 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Harborview Medical Center | Seattle, Washington 98104 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington, Kentucky 40536-0093 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland, Oregon 97227 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Madigan Army Medical Center - Tacoma | Tacoma, Washington 98431 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Rosenfeld Cancer Center at Abington Memorial Hospital | Abington, Pennsylvania 19001 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Valley Cancer Center | Spring Valley, Illinois 61362 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| St. Francis Comprehensive Cancer Center | Topeka, Kansas 66606 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Booker Cancer Center at Riverview Medical Center | Red Bank, New Jersey 07701 |
| Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
| Highland Hospital of Rochester | Rochester, New York 14620 |
| Wayne Radiation Oncology | Goldsboro, North Carolina 27534 |
| Iredell Memorial Hospital | Statesville, North Carolina 28677 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| Firelands Regional Medical Center | Sandusky, Ohio 44870 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| St. Anthony's Memorial Hospital | Effingham, Illinois 62401 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Cancer Center at Ball Memorial Hospital | Muncie, Indiana 47303 |
| South Suburban Oncology Center | Quincy, Massachusetts 02169 |
| Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
| Huron Hospital Cancer Care Center | Cleveland, Ohio 44112 |
| Euclid Hospital | Cleveland, Ohio 44119 |
| Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford | Salem, Ohio 44460 |
| South Pointe Hospital Cancer Care Center | Warrensville Heights, Ohio 44122 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami, Florida 33136 |
| McFarland Clinic, PC | Ames, Iowa 50010 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
| Frederick R. and Betty M. Smith Cancer Treatment Center | Sparta, New Jersey 07871 |
| Leo W. Jenkins Cancer Center at ECU Medical School | Greenville, North Carolina 27834 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland, Oregon 97210 |
| St. Luke's Cancer Network at St. Luke's Hospital | Bethlehem, Pennsylvania 18015 |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
| St. Joseph Cancer Center | Bellingham, Washington 98225 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Schiffler Cancer Center at Wheeling Hospital | Wheeling, West Virginia 26003 |
| Fox Chase Cancer Center CCOP Research Base | Philadelphia, Pennsylvania 19140 |
| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Birmingham, Alabama 35294 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center | Pomona, California 91767 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| Parkview Regional Cancer Center at Parkview Health | Fort Wayne, Indiana 46805 |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
| Three Rivers Community Hospital | Grants Pass, Oregon 97527 |
| Dubs Cancer Center at Rogue Valley Medical Center | Medford, Oregon 97504 |
| Regional Cancer Center at Oconomowoc Memorial Hospital | Oconomowoc, Wisconsin 53066 |
| Kinston Medical Specialists | Kinston, North Carolina 28501 |
| MedCentral - Mansfield Hospital | Mansfield, Ohio 44903 |
| Highlands Oncology Group - Springdale | Springdale, Arkansas 72764 |
| La Grange Memorial Hospital | La Grange, Illinois 60525 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
| Solano Radiation Oncology Center | Vacaville, California 95687 |
| Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare | Vineland, New Jersey 08360 |
| Galesburg Clinic, PC | Galesburg, Illinois 61401 |
| Boston University Cancer Research Center | Boston, Massachusetts 02118 |
| Mercy General Hospital | Sacramento, California 95819 |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea | Scottsdale, Arizona 85260 |
| Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn | Scottsdale, Arizona 85251 |
| Veterans Affairs Medical Center - Indianapolis | Indianapolis, Indiana 46202 |
| Dale and Frances Hughes Cancer Center at Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
| Bay Medical | Panama City, Florida 32401 |
| Cancer Institute of Cape Girardeau, LLC | Cape Girardeau, Missouri 63703 |
| Ocean Medical Center at Meridian Health | Brick, New Jersey 08724 |
| J. Phillip Citta Regional Cancer Center at Community Medical Center | Toms River, New Jersey 08755 |
| Providence Cancer Center at PMCC | Medford, Oregon 97504 |
| Veterans Affairs Medical Center - Milwaukee | Milwaukee, Wisconsin 53295 |
| Memorial Hospital Cancer Center - Colorado Springs | Colorado Springs, Colorado 80909 |
| Hudner Oncology Center at Saint Anne's Hospital - Fall River | Fall River, Massachusetts 02721 |
| Immanuel St. Joseph's | Mankato, Minnesota 56002 |
| Arlington Cancer Center - Arlington | Arlington, Texas 76012 |
| Auburn Radiation Oncology | Auburn, California 95603 |
| Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
| Radiation Oncology Center - Roseville | Roseville, California 95661 |
| Saint John's Cancer Center at Saint John's Medical Center | Anderson, Indiana 46016 |
| Radiation Oncology Associates - Reno | Reno, Nevada 89509 |
| Hudson Valley Oncology Associates | Poughkeepsie, New York 12601 |
| Harrison Medical Center | Bremerton, Washington 98310 |
