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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly
improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in
patients with intermediate-risk factors stage I-IIA cervical cancer after treatment
with radical hysterectomy.

Secondary

- To compare the overall survival (OS) of patients treated with these regimens.

- To assess differences in incidence and severity of regimen-attributed adverse events in
these patients.

- To provide assessment of patient risk vs benefit (positive study only).

- To determine whether post-operative adjuvant CRT improves the health-related
quality-of-life compared to RT alone.

- To compare toxicity profiles with particular focus on treatment-related genitourinary,
gastrointestinal, neurological, pain, and sexual adverse events in these patients.

Tertiary

- 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 treated with these regimens.

- To bank 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 treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to
capillary-lymphovascular space involvement (positive vs negative), stromal invasion (deep vs
middle vs superficial), radiotherapy modality (external-beam radiation therapy [EBRT] vs
intensity-modulated radiation therapy [IMRT]), and cooperative group (KGOG vs GOG). Patients
are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo pelvic EBRT or 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 weeks in the
absence of disease progression or unacceptable toxicity.

Patients complete questionnaires on smoking history, Functional Assessment of Cancer Therapy
(FACT-G, Version 4), FACT-Neurotoxicity subscale, and the Brief Pain Inventory (BPI) at
baseline and periodically during study.

Tumor tissue and blood samples may be collected and banked for future biomarker and other
analysis.

After completion of study therapy, patients are followed up every 3 months for 2 years, and
then every 6 months for 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pathologically confirmed primary cervical cancer comprising one of the following cell
types:

- Squamous cell carcinoma

- Adenosquamous carcinoma

- Adenocarcinoma

- Stage I-IIA disease

- Initially treated with a standard radical hysterectomy with pelvic lymphadenectomy

- Patients with depth of stromal invasion and lymphovascular space involvement to be
pathologically confirmed must meet the following criteria:

- 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

- No patients with tumor in the parametria, pelvic lymph nodes, or any other
extra-uterine site or with positive surgical margins

PATIENT CHARACTERISTICS:

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphate ≤ 3 times ULN

- SGOT ≤ 3 times ULN

- No septicemia or severe infection

- No intestinal obstruction or gastrointestinal bleeding

- No post-operative fistula

- No circumstances that do not permit completion of the study or the required study
follow-up

- No renal abnormalities requiring modification of radiation field (e.g., pelvic kidney
or renal transplant)

- No prior malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 3 weeks but ≤ 8 weeks since surgery

- No prior radiotherapy or chemotherapy for cancer of the cervix

- No prior cancer treatment that contraindicates this protocol therapy

- No concurrent brachytherapy boost

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recurrence-free survival

Safety Issue:

No

Principal Investigator

Sang Y. Ryu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Korea Cancer Center Hospital

Authority:

Unspecified

Study ID:

CDR0000670125

NCT ID:

NCT01101451

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage IA cervical cancer
  • stage IB cervical cancer
  • stage IIA cervical cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • Uterine Cervical Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
MBCCOP - HawaiiHonolulu, Hawaii  96813
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut  06050
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Avera Cancer InstituteSioux Falls, South Dakota  57105
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - ColumbusColumbus, Ohio  43206
University of Texas Medical BranchGalveston, Texas  77555-1329
LDS HospitalSalt Lake City, Utah  84143
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
SUNY Downstate Medical CenterBrooklyn, New York  11203
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Sibley Memorial HospitalWashington, District of Columbia  20016
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
St. Luke's - Roosevelt Hospital Center - St.Luke's DivisionNew York, New York  10027
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Bismarck Cancer CenterBismarck, North Dakota  58501
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
McFarland Clinic, PCAmes, Iowa  50010
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
Legacy Good Samaritan Hospital & Comprehensive Cancer CenterPortland, Oregon  97210
Northwest Cancer Specialists at Rose Quarter Cancer CenterPortland, Oregon  97227
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
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
Woman's HospitalBaton Rouge, Louisiana  70815
Mid Dakota Clinic, PCBismarck, North Dakota  58501
Methodist HospitalHouston, Texas  77030
Gynecologic OncologyHinsdale, Illinois  60521
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
Valley Hospital - RidgewoodRidgewood, New Jersey  07450
Medcenter One Hospital Cancer Care CenterBismarck, North Dakota  58501
St. Alexius Medical Center Cancer CenterBismarck, North Dakota  58502
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Holy Cross HospitalSilver Spring, Maryland  20910
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Southwest Gynecologic Oncology Associates, IncorporatedAlbuquerque, New Mexico  87102
Women's Cancer Care AssociatesAlbany, New York  12208
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
University of New Mexico Cancer Center - SouthLas Cruces, New Mexico  88011
St. Vincent Oncology CenterIndianapolis, Indiana  46260
Women's Institute for Gynecologic Cancer and Special Pelvic SurgeryPhillipsburg, New Jersey  08865