NCT00057746

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer while taking into account chronic neurotoxicity from radiation therapy. PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
265

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2 lung-cancer

Geographic Reach
2 countries

222 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2003

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

May 25, 2016

Completed
Last Updated

May 25, 2016

Status Verified

April 1, 2016

Enrollment Period

6.2 years

First QC Date

April 7, 2003

Results QC Date

April 18, 2016

Last Update Submit

April 18, 2016

Conditions

Keywords

limited stage small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Chronic Neurotoxicity

    Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.

    From study registration to one year.

Study Arms (3)

Arm I

ACTIVE COMPARATOR

Prophylactic cranial irradiation, 2.5 Gy fx

Radiation: Prophylactic cranial irradiation, 2.5 Gy fx

Arm II

EXPERIMENTAL

Prophylactic cranial irradiation, 2.0 Gy fx

Radiation: Prophylactic cranial irradiation, 2.0 Gy fx

Arm III

EXPERIMENTAL

Prophylactic cranial irradiation, 1.5 Gy fx

Radiation: Prophylactic cranial irradiation, 1.5 Gy fx

Interventions

Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions (fx) for a total of 25 Gy

Also known as: PCI
Arm I

Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions (fx) for a total of 36 Gy

Also known as: PCI
Arm II

Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions (fx) for a total dose of 36 Gy

Also known as: PCI
Arm III

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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 based on malignant pleural effusion, or N3 disease based on contralateral hilar or contralateral supraclavicular involvement * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (222)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn

Scottsdale, Arizona, 85251, United States

Location

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale, Arizona, 85260, United States

Location

Highlands Oncology Group - Springdale

Springdale, Arkansas, 72764, United States

Location

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Rebecca and John Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Radiation Oncology Center - Roseville

Roseville, California, 95661, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

Solano Radiation Oncology Center

Vacaville, California, 95687, United States

Location

Memorial Hospital Cancer Center - Colorado Springs

Colorado Springs, Colorado, 80909, United States

Location

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, 81502, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

Baptist-South Miami Regional Cancer Program

Miami, Florida, 33176, United States

Location

Bay Medical

Panama City, Florida, 32401, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Northwest Community Hospital

Arlington Heights, Illinois, 60005, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

St. Joseph Medical Center

Bloomington, Illinois, 61701, United States

Location

Graham Hospital

Canton, Illinois, 61520, United States

Location

Memorial Hospital

Carthage, Illinois, 62321, United States

Location

St. Anthony's Memorial Hospital

Effingham, Illinois, 62401, United States

Location

Eureka Community Hospital

Eureka, Illinois, 61530, United States

Location

Galesburg Clinic, PC

Galesburg, Illinois, 61401, United States

Location

Galesburg Cottage Hospital

Galesburg, Illinois, 61401, United States

Location

InterCommunity Cancer Center of Western Illinois

Galesburg, Illinois, 61401, United States

Location

Mason District Hospital

Havana, Illinois, 62644, United States

Location

Hopedale Medical Complex

Hopedale, Illinois, 61747, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Kewanee Hospital

Kewanee, Illinois, 61443, United States

Location

La Grange Memorial Hospital

La Grange, Illinois, 60525, United States

Location

McDonough District Hospital

Macomb, Illinois, 61455, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

BroMenn Regional Medical Center

Normal, Illinois, 61761, United States

Location

Community Cancer Center

Normal, Illinois, 61761, United States

Location

Community Hospital of Ottawa

Ottawa, Illinois, 61350, United States

Location

Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, 61554, United States

Location

Proctor Hospital

Peoria, Illinois, 61614, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615, United States

Location

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, 61615, United States

Location

Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Illinois Valley Community Hospital

Peru, Illinois, 61354, United States

Location

Perry Memorial Hospital

Princeton, Illinois, 61356, United States

Location

St. Margaret's Hospital

Spring Valley, Illinois, 61362, United States

Location

Valley Cancer Center

Spring Valley, Illinois, 61362, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Saint John's Cancer Center at Saint John's Medical Center

Anderson, Indiana, 46016, United States

Location

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, 46805, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Veterans Affairs Medical Center - Indianapolis

Indianapolis, Indiana, 46202, United States

Location

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, 46350, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Cancer Center at Ball Memorial Hospital

Muncie, Indiana, 47303-3499, United States

Location

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

Location

McFarland Clinic, PC

Ames, Iowa, 50010, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, 66720, United States

Location

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, 67801, United States

Location

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, 67042, United States

Location

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, 67068, United States

Location

Southwest Medical Center

Liberal, Kansas, 67901, United States

Location

Cancer Center of Kansas, PA - Newton

Newton, Kansas, 67114, United States

Location

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, 67357, United States

Location

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, 67124, United States

Location

Cancer Center of Kansas, PA - Salina

Salina, Kansas, 67042, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66606, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Cancer Center of Kansas, PA - Wellington

Wellington, Kansas, 67152, United States

Location

Associates in Womens Health, PA - North Review

Wichita, Kansas, 67203, United States

Location

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita, Kansas, 67208, United States

Location

Cancer Center of Kansas, PA - Wichita

Wichita, Kansas, 67214, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214, United States

Location

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Cancer Center of Kansas, PA - Winfield

Winfield, Kansas, 67156, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River, Massachusetts, 02721, United States

Location

South Suburban Oncology Center

Quincy, Massachusetts, 02169, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor, Michigan, 48105, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Metro Health Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49001, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Hackley Hospital

Muskegon, Michigan, 49442, United States

Location

Lakeland Regional Cancer Care Center - St. Joseph

Saint Joseph, Michigan, 49085, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Immanuel St. Joseph's

Mankato, Minnesota, 56002, United States

Location

CentraCare Clinic - River Campus

Saint Cloud, Minnesota, 56303, United States

Location

Regional Cancer Center at Singing River Hospital

Pascagoula, Mississippi, 39581, United States

Location

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, 63703, United States

Location

CCOP - St. Louis-Cape Girardeau

St Louis, Missouri, 63141, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

CCOP - Nevada Cancer Research Foundation

Las Vegas, Nevada, 89106, United States

Location

Radiation Oncology Associates - Reno

Reno, Nevada, 89509, United States

Location

Ocean Medical Center at Meridian Health

Brick, New Jersey, 08724, United States

Location

John F. Kennedy Medical Center

Edison, New Jersey, 08818, United States

Location

Monmouth Medical Center

Long Branch, New Jersey, 07740-6395, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Booker Cancer Center at Riverview Medical Center

Red Bank, New Jersey, 07701, United States

Location

Frederick R. and Betty M. Smith Cancer Treatment Center

Sparta, New Jersey, 07871, United States

Location

J. Phillip Citta Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

Vineland, New Jersey, 08360, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, 10940-4199, United States

Location

Hudson Valley Oncology Associates

Poughkeepsie, New York, 12601, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

SUNY Upstate Medical University Hospital

Syracuse, New York, 13210, United States

Location

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte, North Carolina, 28233-3549, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville, North Carolina, 27835-6028, United States

Location

Kinston Medical Specialists

Kinston, North Carolina, 28501, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Aultman Cancer Center at Aultman Hospital

Canton, Ohio, 44710-1799, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Huron Hospital Cancer Care Center

Cleveland, Ohio, 44112, United States

Location

Euclid Hospital

Cleveland, Ohio, 44119, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

St. Rita's Medical Center

Lima, Ohio, 45801, United States

Location

Lima Memorial Hospital

Lima, Ohio, 45804, United States

Location

MedCentral - Mansfield Hospital

Mansfield, Ohio, 44903, United States

Location

St. Luke's Hospital

Maumee, Ohio, 43537, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem, Ohio, 44460, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Mercy Hospital of Tiffin

Tiffin, Ohio, 44883, United States

Location

Toledo Hospital

Toledo, Ohio, 43606, United States

Location

St. Vincent Mercy Medical Center

Toledo, Ohio, 43608, United States

Location

Medical University of Ohio Cancer Center

Toledo, Ohio, 43614, United States

Location

CCOP - Toledo Community Hospital

Toledo, Ohio, 43617, United States

Location

Toledo Clinic, Incorporated - Main Clinic

Toledo, Ohio, 43623, United States

Location

South Pointe Hospital Cancer Care Center

Warrensville Heights, Ohio, 44122, United States

Location

Cancer Treatment Center

Wooster, Ohio, 44691, United States

Location

Three Rivers Community Hospital

Grants Pass, Oregon, 97527, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Dubs Cancer Center at Rogue Valley Medical Center

Medford, Oregon, 97504, United States

Location

Providence Cancer Center at PMCC

Medford, Oregon, 97504, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

St. Luke's Cancer Network at St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, 19140, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

York Cancer Center at Apple Hill Medical Center

York, Pennsylvania, 17405, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

CCOP - Greenville

Greenville, South Carolina, 29615, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Arlington Cancer Center - Arlington

Arlington, Texas, 76012-2510, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray, Utah, 84157, United States

Location

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Harrison Medical Center

Bremerton, Washington, 98310, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Madigan Army Medical Center - Tacoma

Tacoma, Washington, 98431, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Schiffler Cancer Center at Wheeling Hospital

Wheeling, West Virginia, 26003, United States

Location

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54301-3526, United States

Location

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay, Wisconsin, 54303, United States

Location

St. Mary's Hospital Medical Center - Green Bay

Green Bay, Wisconsin, 54303, United States

Location

St. Vincent Hospital Regional Cancer Center

Green Bay, Wisconsin, 54307-3508, United States

Location

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601, United States

Location

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette, Wisconsin, 54143, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

Regional Cancer Center at Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066, United States

Location

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine, Wisconsin, 53405, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Centre Hospitalier Universitaire de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

McGill Cancer Centre at McGill University

Montreal, H2W 1S6, Canada

Location

Related Publications (4)

  • Gondi V, Paulus R, Bruner D, et al.: Prognostic significance of QOL deterioration during early lung cancer survivorship: secondary analysis of RTOG 0212 and 0214. [Abstract] J Clin Oncol 29 (Suppl 15): A-6061, 2011.

    BACKGROUND
  • Le Pechoux C, Dunant A, Senan S, Wolfson A, Quoix E, Faivre-Finn C, Ciuleanu T, Arriagada R, Jones R, Wanders R, Lerouge D, Laplanche A; Prophylactic Cranial Irradiation (PCI) Collaborative Group. Standard-dose versus higher-dose prophylactic cranial irradiation (PCI) in patients with limited-stage small-cell lung cancer in complete remission after chemotherapy and thoracic radiotherapy (PCI 99-01, EORTC 22003-08004, RTOG 0212, and IFCT 99-01): a randomised clinical trial. Lancet Oncol. 2009 May;10(5):467-74. doi: 10.1016/S1470-2045(09)70101-9. Epub 2009 Apr 20.

    PMID: 19386548BACKGROUND
  • Pechoux CL, Hatton M, Kobierska A, et al.: Randomized trial of standard dose to a higher dose prophylactic cranial irradiation (PCI) in limited-stage small cell cancer (SCLC) complete responders (CR): primary endpoint analysis (PCI99-01, IFCT 99-01, EORTC 22003-08004, RTOG 0212). [Abstract] J Clin Oncol 26 (Suppl 15): A-LBA7514, 2008.

    BACKGROUND
  • Wolfson AH, Bae K, Komaki R, Meyers C, Movsas B, Le Pechoux C, Werner-Wasik M, Videtic GM, Garces YI, Choy H. Primary analysis of a phase II randomized trial Radiation Therapy Oncology Group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):77-84. doi: 10.1016/j.ijrobp.2010.05.013. Epub 2010 Aug 26.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

The number of inevaluable patients at one year (e.g., patients dying prior to 1 year, patients not completing the neurocognitive battery at 1 year) was greater than anticipated.

Results Point of Contact

Title
Wendy Seiferheld
Organization
NRG Onoclogy

Study Officials

  • Aaron H. Wolfson, MD

    University of Miami Sylvester Comprehensive Cancer Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2003

First Posted

April 9, 2003

Study Start

February 1, 2003

Primary Completion

May 1, 2009

Study Completion

November 1, 2013

Last Updated

May 25, 2016

Results First Posted

May 25, 2016

Record last verified: 2016-04

Locations