Radiation Therapy with or without Chemotherapy in Patients with Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Inclusion Criteria
- Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy
- Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed): * Positive capillary-lymphovascular space involvement and one of the following: ** Deep third penetration ** Middle third penetration, clinical tumor >= 2 cm ** Superficial third penetration, clinical tumor >= 5 cm * Negative capillary-lymphatic space involvement ** Middle or deep third penetration, clinical tumor >= 4 cm
- Absolute neutrophil count (ANC) >= 1,500/mcl
- Platelets >= 100,000/mcl
- Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60 mL/min
- Bilirubin =< 1.5 x normal
- Alkaline phosphate =< 3 x normal
- Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal
- Gynecologic Oncology Group (GOG) performance status 0, 1, 2
- Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery
- Patients who have met the pre-entry requirements
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria
- Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins
- Patients with septicemia or severe infection
- Patients with intestinal obstruction or gastrointestinal bleeding
- Patients with postoperative fistula
- Patients with cervix cancer who have received any previous radiation or chemotherapy
- Patients whose circumstances do not permit completion of the study or the required follow-up
- Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc.)
- Patients with GOG performance status of 3 or 4
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Alaska
Anchorage
Fairbanks
Arizona
Phoenix
Arkansas
Ft. Smith
Hot Springs
California
Arroyo Grande
Auburn
Berkeley
Burbank
Burlingame
Cameron Park
Carmichael
Castro Valley
Concord
Davis
Elk Grove
Loma Linda
Los Angeles
Modesto
Mountain View
Novato
Orange
Palo Alto
Pomona
Rocklin
Roseville
Sacramento
San Francisco
Santa Cruz
Santa Rosa
Sunnyvale
Sylmar
Vacaville
Vallejo
Walnut Creek
Woodland
Colorado
Aurora
Boulder
Colorado Springs
Denver
Durango
Englewood
Golden
Grand Junction
Greeley
Greenwood Village
Lakewood
Littleton
Lone Tree
Longmont
Loveland
Parker
Pueblo
Thornton
Wheat Ridge
Connecticut
Hartford
New Britain
New Haven
District of Columbia
Washington
Florida
Altamonte Springs
Deerfield Beach
Fort Lauderdale
Kissimmee
Miami
Orlando
Winter Park
Georgia
Atlanta
Columbus
Decatur
Gainesville
Marietta
Riverdale
Savannah
Hawaii
Honolulu
Idaho
Boise
Caldwell
Coeur D'Alene
Emmett
Fruitland
Meridian
Nampa
Post Falls
Sandpoint
Twin Falls
Illinois
Alton
Aurora
Bloomington
Canton
Carbondale
Carterville
Carthage
Centralia
Chicago
Danville
Decatur
Effingham
Eureka
Galesburg
Geneva
Hinsdale
Kewanee
Macomb
Mattoon
Maywood
Mount Vernon
O'Fallon
Ottawa
Pekin
Peoria
Peru
Princeton
Springfield
Swansea
Urbana
Warrenville
Yorkville
Indiana
Evansville
Fort Wayne
Indianapolis
Mishawaka
Newburgh
Richmond
South Bend
Iowa
Ames
Boone
Clive
Creston
Des Moines
Fort Dodge
Iowa City
Jefferson
Marshalltown
Sioux City
Spencer
West Des Moines
Kansas
Kansas City
Kentucky
Crestview Hills
Lexington
Louisville
Pikeville
Louisiana
Baton Rouge
Covington
New Orleans
Maine
Bath
Portland
Sanford
Scarborough
Maryland
Baltimore
Bethesda
Silver Spring
Massachusetts
Springfield
Michigan
Ann Arbor
Battle Creek
Brighton
Canton
Caro
Chelsea
Clarkston
Dearborn
Detroit
East China
Flint
Grand Blanc
Grand Rapids
Grosse Pointe Woods
Jackson
Kalamazoo
Lansing
Livonia
Macomb Township
Marlette
Monroe
Muskegon
Niles
Norton Shores
Novi
Pontiac
Port Huron
Reed City
Rochester Hills
Saginaw
Saint Joseph
Southfield
Sterling Heights
Traverse City
Warren
West Branch
Wyoming
Ypsilanti
Minnesota
Bemidji
Burnsville
Coon Rapids
Edina
Fridley
Hutchinson
Maple Grove
Maplewood
Minneapolis
Monticello
New Ulm
Robbinsdale
Rochester
Saint Louis Park
Saint Paul
Shakopee
Stillwater
Waconia
Willmar
Woodbury
Wyoming
Mississippi
Jackson
Pascagoula
Missouri
Bolivar
Bonne Terre
Branson
Cape Girardeau
Columbia
Jefferson City
Joplin
Rolla
Saint Joseph
Saint Louis
Sainte Genevieve
Springfield
Sullivan
Sunset Hills
Montana
Anaconda
Billings
Bozeman
Butte
Great Falls
Helena
Kalispell
Missoula
Nebraska
Grand Island
Kearney
Omaha
Nevada
Henderson
Las Vegas
Reno
New Hampshire
Lebanon
New Jersey
Basking Ridge
Lakewood
Long Branch
Middletown
Moorestown
Mount Holly
Mullica Hill
Newark
Paramus
Phillipsburg
Ridgewood
Toms River
Vineland
Voorhees
Westwood
New Mexico
Albuquerque
Las Cruces
Rio Rancho
New York
Albany
Bronx
Brooklyn
Commack
New York
Rochester
Sleepy Hollow
Stony Brook
Uniondale
West Harrison
North Carolina
Asheboro
Burlington
Chapel Hill
Charlotte
Clinton
Goldsboro
Greensboro
Huntersville
Jacksonville
Matthews
Mebane
Mooresville
Reidsville
Winston-Salem
North Dakota
Bismarck
Fargo
Ohio
Akron
Belpre
Centerville
Chillicothe
Cincinnati
Cleveland
Columbus
Dayton
Delaware
Dublin
Fairfield
Findlay
Franklin
Greenville
Grove City
Kettering
Lancaster
Mansfield
Marietta
Marion
Mayfield Heights
Mentor
Middletown
Mount Vernon
Newark
Portsmouth
Sidney
Springfield
Sylvania
Toledo
Troy
WPAFB
West Chester
Westerville
Zanesville
Oklahoma
Oklahoma City
Tulsa
Oregon
Baker City
Bend
Clackamas
Coos Bay
Gresham
Newberg
Ontario
Oregon City
Portland
Tualatin
Pennsylvania
Abington
Allentown
Bethlehem
Danville
East Stroudsburg
Easton
Lewisburg
Lewistown
Philadelphia
Pittsburgh
Pottsville
West Reading
Wilkes-Barre
Willow Grove
Rhode Island
Providence
South Carolina
Boiling Springs
Easley
Greenville
Greer
Seneca
South Dakota
Rapid City
Sioux Falls
Tennessee
Knoxville
Texas
Austin
Bryan
Dallas
Galveston
Houston
League City
Sugar Land
Utah
American Fork
Cedar City
Logan
Murray
Ogden
Provo
Riverton
Saint George
Salt Lake City
Virginia
Portsmouth
Richmond
Washington
Aberdeen
Anacortes
Auburn
Bainbridge Island
Bellevue
Bellingham
Bremerton
Burien
Centralia
Edmonds
Everett
Federal Way
Gig Harbor
Issaquah
Kennewick
Kirkland
Lacey
Longview
Lynnwood
Mount Vernon
Port Angeles
Port Townsend
Poulsbo
Puyallup
Renton
Seattle
Sequim
Shelton
Spokane
Spokane Valley
Tacoma
Vancouver
Walla Walla
Wenatchee
Yakima
Yelm
West Virginia
Wheeling
Wisconsin
Fond Du Lac
Grafton
Green Bay
La Crosse
Madison
Marinette
Milwaukee
New Richmond
Oshkosh
Sheboygan
Summit
Two Rivers
West Allis
Wyoming
Cheyenne
Cody
Sheridan
Japan
Kagoshima City
Kure
Matsuyama
Niigata City
Osaka
Sendai
Shiwa-gun
Shizuoka City
Korea, Republic of
Dalseo-gu
Goyang-si
Incheon
Jung-gu
Seongnam City
Seoul
PRIMARY OBJECTIVE:
I. To determine if post-operative adjuvant chemo-radiation therapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in stage I-IIA cervical cancer patients with intermediate-risk factors after treatment with radical hysterectomy.
SECONDARY OBJECTIVES:
I. To determine whether post-operative adjuvant CRT can improve overall survival (OS) when compared to RT alone in stage I-IIA cervical cancer patients with intermediate risk factors after treatment with radical hysterectomy.
II. To assess differences (across treatment arms) in incidence and severity of therapy attributed adverse events utilizing the active version of Common Terminology Criteria for Adverse Events (CTCAE).
III. To provide assessment of patient risk version (vs) benefit (positive study only).
QUALITY OF LIFE OBJECTIVE:
I. To determine whether post-operative adjuvant CRT improves the health-related quality-of-life (QOL) (compared to RT alone) as measured by Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) Trial Outcome Index (TOI) and produce favorable toxicity profiles (with particular focus on treatment related genitourinary, gastrointestinal, neurological, pain and sexual adverse events).
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To bank archival tumor tissue for research studies, including studies that evaluate the association between biomarkers, RFS, OS, and clinical-surgical-pathologic characteristics in patients randomized to post-operative adjuvant CRT compared to RT alone.
II. To bank deoxyribonucleic acid (DNA) from whole blood for research studies, including studies that evaluate associations between single nucleotide polymorphisms (SNPs), and measures of clinical outcome, including RFS, OS, and adverse events in patients randomized to post-operative adjuvant CRT compared to RT alone.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo pelvic external-beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) 5 days a week for 5.5 weeks.
ARM II: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Trial Phase Phase III
Trial Type Treatment
Lead Organization
NRG Oncology
Principal Investigator
Sang Young Ryu
- Primary ID GOG-0263
- Secondary IDs NCI-2011-02037, CDR0000670125
- Clinicaltrials.gov ID NCT01101451