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GOG 0263: RANDOMIZED PHASE III CLINICAL TRIAL OF ADJUVANT RADIATION VERSUS CHEMORADIATION IN INTERMEDIATE RISK, STAGE I/IIA CERVICAL CANCER TREATED WITH INITIAL RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY

Description

PRIMARY OBJECTIVES: 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 vs benefit (positive study only). IV. 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). TERTIARY 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.

Phase

Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.

Inclusion and Exclusion 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 times normal
  • Alkaline phosphate ≤ 3 times normal
  • Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times 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

  • 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

Sites

  • California

    • USC / Norris Comprehensive Cancer Center, Los Angeles, California, 90033
    • Los Angeles County-USC Medical Center, Los Angeles, California, 90033
    • University of Southern California/Norris Cancer Center, Los Angeles, California, 90033
    • Cedars-Sinai Medical Center, Los Angeles, California, 90048
    • Cedars-Sinai Medical Center, Los Angeles, California, 90048
    • Roy and Patricia Disney Family Cancer Center, Burbank, California, 91505
    • Providence Saint Joseph Medical Center/Disney Family Cancer Center, Burbank, California, 91505
    • Olive View-University of California Los Angeles Medical Center, Sylmar, California, 91342
    • Pomona Valley Hospital Medical Center, Pomona, California, 91767
    • Memorial Medical Center, Modesto, California, 95355
    • Palo Alto Medical Foundation-Santa Cruz, Santa Cruz, California, 95065
    • Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040
    • Palo Alto Medical Foundation-Camino Division, Mountain View, California, 94040
    • Palo Alto Medical Foundation-Gynecologic Oncology, Mountain View, California, 94040
    • Palo Alto Medical Foundation Health Care, Palo Alto, California, 94301
    • Mills - Peninsula Hospitals, Burlingame, California, 94010
    • John Muir Medical Center, Walnut Creek, California, 94598
    • John Muir Medical Center-Concord Campus, Concord, California, 94520
    • Alta Bates Summit Medical Center-Herrick Campus, Berkeley, California, 94704
    • California Pacific Medical Center-Pacific Campus, San Francisco, California, 94118
    • Sutter Cancer Centers Radiation Oncology Services-Cameron Park, Cameron Park, California, 95682
    • Palo Atlo Medical Foundation-Sunnyvale, Sunnyvale, California, 94806
    • Sutter General Hospital, Sacramento, California, 95816
    • Sutter Solano Medical Center/Cancer Center, Vallejo, California, 94589
    • Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, 95687
    • Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, 95661
    • Sutter Roseville Medical Center, Roseville, California, 95661
    • Sutter Davis Hospital, Davis, California, 95616
    • Sutter Cancer Research Consortium, Novato, California, 94945
    • Sutter Cancer Centers Radiation Oncology Services-Auburn, Auburn, California, 95603
    • Sutter Auburn Faith Hospital, Auburn, California, 95602
    • Sutter Pacific Medical Foundation, Santa Rosa, California, 95403
  • Utah

    • Dixie Medical Center Regional Cancer Center, Saint George, Utah, 84770
    • Sandra L Maxwell Cancer Center, Cedar City, Utah, 84720
    • Sandra L Maxwell Cancer Center, Cedar City, Utah, 84720
    • Utah Valley Regional Medical Center, Provo, Utah, 84604
    • Huntsman Intermountain Cancer Center-American Fork Hospital, American Fork, Utah, 84003
    • American Fork Hospital / Huntsman Intermountain Cancer Center, American Fork, Utah, 84003
    • Intermountain Medical Center, Murray, Utah, 84157
    • Utah Cancer Specialists-Salt Lake City, Salt Lake City, Utah, 84106
    • LDS Hospital, Salt Lake City, Utah, 84143
    • LDS Hospital, Salt Lake City, Utah, 84143
    • Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, 84112
    • McKay-Dee Hospital Center, Ogden, Utah, 84403
    • McKay-Dee Hospital Center, Ogden, Utah, 84403
    • Logan Regional Hospital, Logan, Utah, 84321
    • Logan Regional Hospital, Logan, Utah, 84321
  • Arizona

    • Saint Joseph's Hospital and Medical Center, Phoenix, Arizona, 85013
  • Nevada

    • Center of Hope at Renown Medical Center, Reno, Nevada, 89502
    • Renown Regional Medical Center, Reno, Nevada, 89502
  • Colorado

    • Southwest Oncology PC, Durango, Colorado, 81301
    • Sky Ridge Medical Center, Lone Tree, Colorado, 80124
  • New Mexico

    • University of New Mexico, Albuquerque, New Mexico, 87106
    • University of New Mexico Cancer Center, Albuquerque, New Mexico, 87106
    • Southwest Gynecologic Oncology Associates Inc, Albuquerque, New Mexico, 87106
    • Memorial Medical Center - Las Cruces, Las Cruces, New Mexico, 88011
  • Washington

    • Providence Saint Mary Regional Cancer Center, Walla Walla, Washington, 99362
    • Wenatchee Valley Medical Center, Wenatchee, Washington, 98801
    • Tacoma General Hospital, Tacoma, Washington, 98405
    • Saint Joseph Medical Center, Tacoma, Washington, 98405
    • Rockwood Cancer Treatment Center-DHEC-Downtown, Spokane, Washington, 99204
    • Cancer Care Northwest - Spokane South, Spokane, Washington, 99202
    • University of Washington Medical Center, Seattle, Washington, 98195
    • Olympic Medical Cancer Care Center, Sequim, Washington, 98384
    • Pacific Gynecology Specialists, Seattle, Washington, 98104
    • Group Health Cooperative-Seattle, Seattle, Washington, 98112
    • Seattle Cancer Care Alliance, Seattle, Washington, 98109
    • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, 98109
    • Harrison HealthPartners Hematology and Oncology-Bremerton, Bremerton, Washington, 98310
    • Harrison Medical Center, Bremerton, Washington, 98310
    • Northwest Hospital, Seattle, Washington, 98133
    • Harrison HealthPartners Hematology and Oncology-Poulsbo, Poulsbo, Washington, 98370
    • Providence Regional Cancer Partnership, Everett, Washington, 98201
    • Skagit Valley Hospital Regional Cancer Care Center, Mount Vernon, Washington, 98273
    • PeaceHealth Medical Group PC, Bellingham, Washington, 98226
  • Oregon

    • Legacy Good Samaritan Hospital and Medical Center, Portland, Oregon, 97210
    • Compass Oncology Rose Quarter, Portland, Oregon, 97227
  • Wyoming

    • Cheyenne Regional Medical Center-West, Cheyenne, Wyoming, 82001
  • South Dakota

    • Black Hills Obstetrics and Gynecology, Rapid City, South Dakota, 57701
    • Rapid City Regional Hospital, Rapid City, South Dakota, 57701
    • Avera Cancer Institute, Sioux Falls, South Dakota, 57105
  • Oklahoma

    • University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104
    • Tulsa Cancer Institute, Tulsa, Oklahoma, 74146
  • Texas

    • University Medical Center Brackenridge, Austin, Texas, 78701
    • Parkland Memorial Hospital, Dallas, Texas, 75235
    • University of Texas Southwestern Medical Center, Dallas, Texas, 75390
    • Methodist Hospital, Houston, Texas, 77030
    • Memorial Hermann Texas Medical Center, Houston, Texas, 77030
  • North Dakota

    • Bismarck Cancer Center, Bismarck, North Dakota, 58501
    • Saint Alexius Medical Center, Bismarck, North Dakota, 58501
    • Sanford Bismarck Medical Center, Bismarck, North Dakota, 58501
    • Mid Dakota Clinic, Bismarck, North Dakota, 58501
  • Nebraska

    • Nebraska Methodist Hospital, Omaha, Nebraska, 68114
  • Iowa

    • Siouxland Hematology Oncology Associates, Sioux City, Iowa, 51101
    • Abben Cancer Center, Spencer, Iowa, 51301
    • University of Iowa Hospitals and Clinics, Iowa City, Iowa, 52242
  • Kansas

    • University of Kansas Medical Center, Kansas City, Kansas, 66160
  • Minnesota

    • Rice Memorial Hospital, Willmar, Minnesota, 56201
    • New Ulm Medical Center, New Ulm, Minnesota, 56073
    • Hutchinson Area Health Care, Hutchinson, Minnesota, 55350
    • Ridgeview Medical Center, Waconia, Minnesota, 55387
    • Saint Francis Regional Medical Center, Shakopee, Minnesota, 55379
    • Fairview-Southdale Hospital, Edina, Minnesota, 55435
    • Fairview Ridges Hospital, Burnsville, Minnesota, 55337
    • Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, 55416
    • Metro-Minnesota CCOP, Saint Louis Park, Minnesota, 55416
    • North Memorial Medical Health Center, Robbinsdale, Minnesota, 55422
    • Abbott-Northwestern Hospital, Minneapolis, Minnesota, 55407
    • Hennepin County Medical Center, Minneapolis, Minnesota, 55415
    • Mercy Hospital, Coon Rapids, Minnesota, 55433
    • Unity Hospital, Fridley, Minnesota, 55432
    • United Hospital, Saint Paul, Minnesota, 55102
    • Regions Hospital, Saint Paul, Minnesota, 55101
    • Saint John's Hospital - Healtheast, Maplewood, Minnesota, 55109
    • Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, 55109
    • Minnesota Oncology and Hematology PA-Woodbury, Woodbury, Minnesota, 55125
    • Mayo Clinic, Rochester, Minnesota, 55905
    • Lakeview Hospital, Stillwater, Minnesota, 55082
  • Missouri

    • University of Missouri - Ellis Fischel, Columbia, Missouri, 65212
    • Phelps County Regional Medical Center, Rolla, Missouri, 65401
    • Missouri Baptist Sullivan Hospital, Sullivan, Missouri, 63080
    • Parkland Health Center-Bonne Terre, Bonne Terre, Missouri, 63628
    • Saint Louis-Cape Girardeau CCOP, Saint Louis, Missouri, 63141
    • Missouri Baptist Outpatient Center-Sunset Hills, Sunset Hills, Missouri, 63127
    • Sainte Genevieve County Memorial Hospital, Sainte Genevieve, Missouri, 63670
  • Wisconsin

    • Cancer Center of Western Wisconsin, New Richmond, Wisconsin, 54017
    • Aurora Medical Center in Summit, Summit, Wisconsin, 53066
    • Aurora Medical Center in Summit, Summit, Wisconsin, 53066
    • Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, 54904
    • Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, 54904
    • Aurora West Allis Medical Center, West Allis, Wisconsin, 53227
    • Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
    • Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, 53215
    • Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, 53215
    • Aurora Sinai Medical Center, Milwaukee, Wisconsin, 53233
    • Aurora Cancer Care-Grafton, Grafton, Wisconsin, 53024
    • Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, 53081
    • Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, 53081
    • Vince Lombardi Cancer Clinic, Two Rivers, Wisconsin, 54241
    • Vince Lombardi Cancer Clinic, Two Rivers, Wisconsin, 54241
    • Vince Lombardi Cancer Clinic-Marinette, Marinette, Wisconsin, 54143
    • Vince Lombardi Cancer Clinic-Marinette, Marinette, Wisconsin, 54143
  • Louisiana

    • Woman's Hospital, Baton Rouge, Louisiana, 70817
  • Mississippi

    • University of Mississippi Medical Center, Jackson, Mississippi, 39216
  • Illinois

    • Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, 60521
    • Loyola University Medical Center, Maywood, Illinois, 60153
  • Indiana

    • Saint Vincent Oncology Center, Indianapolis, Indiana, 46260
    • Indiana University Medical Center, Indianapolis, Indiana, 46202
    • Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, 46202
  • Ohio

    • University of Cincinnati, Cincinnati, Ohio, 45267
    • Grandview Hospital, Dayton, Ohio, 45405
    • Grandview Hospital, Dayton, Ohio, 45405
    • Kettering Medical Center, Kettering, Ohio, 45429
  • Kentucky

    • University of Kentucky/Markey Cancer Center, Lexington, Kentucky, 40536
    • University of Kentucky, Lexington, Kentucky, 40536
  • Georgia

    • John B Amos Cancer Center, Columbus, Georgia, 31904
    • Wellstar Kennestone Hospital, Marietta, Georgia, 30060
    • Northside Hospital, Atlanta, Georgia, 30342
    • Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, 30342
    • Southern Regional Medical Center, Riverdale, Georgia, 30274
    • Emory University/Winship Cancer Institute, Atlanta, Georgia, 30322
    • Emory University/Winship Cancer Institute, Atlanta, Georgia, 30322
    • Dekalb Medical Center, Decatur, Georgia, 30033
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