Fact CheckerSign in

NCT00980954CompletedPhase 3

Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy With or Without Adjuvant Chemotherapy in High-Risk Patients With Early-Stage Cervical Carcinoma Following Radical Hysterectomy

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Brief summary (registry, in English)

RATIONALE: Drugs used in chemotherapy, such as cisplatin, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether chemotherapy and radiation therapy are more effective when given with or without additional chemotherapy in treating cervical cancer. PURPOSE: This randomized phase III trial is studying chemotherapy and pelvic radiation therapy to see how well they work when given with or without additional chemotherapy in treating patients with high-risk early-stage cervical cancer after radical hysterectomy.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
236 (actual)
First submitted
18 Sept 2009
Start date
Sept 2009
Primary completion date
14 Dec 2023
Lead sponsor
Radiation Therapy Oncology Group
NCT number
NCT00980954

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 236
  • From Sept 2009 to the primary completion date, 14 Dec 2023
  • 125 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed squamous, adenosquamous, or adenocarcinoma of the cervix with any/all of the following high-risk features after surgery:
    • Positive pelvic nodes
    • Positive parametrium
    • Positive para-aortic nodes that have been completely resected and are positron emission tomography (PET)/computed tomography (CT) scan-negative
    • PET only required if positive para-aortic nodes during surgery
  • Clinical stage IA2, IB, or IIA disease (this corresponds to surgical tumor node metastasis (TNM) staging of T1-T2, N1, M0)
  • Must have undergone radical hysterectomy (open, laparoscopically, or robotic) and staging within the past 70 days
    • Para-aortic and pelvic node sampling required
    • If the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a PET-CT is recommended, but not required
    • A negative pre- or post-operative PET scan or PET-CT scan of the para-aortic nodes is required if the patient did not undergo para-aortic or common iliac nodal sampling/dissection
    • No gross residual disease
  • No neuroendocrine histology
  • No distant metastases
    • PATIENT CHARACTERISTICS:
  • Zubrod performance status 0-1
  • Absolute neutrophil count (ANC) ≥ 1,800/mm³
  • Platelets ≥ 100,000/mm³
  • White blood cell count (WBC) ≥ 4,000/mm³
  • Hemoglobin ≥ 10.0 g/dL (transfusion or other intervention allowed)
  • Serum creatinine ≤ 1.5 mg/dL
  • Bilirubin ≤ 1.5 times upper limit of normal
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) normal
  • Alkaline phosphatase normal
  • Known HIV positivity allowed provided cluster of differentiation 4 (CD4) count is ≥ 350/mm³ within the past 14 days
  • No other invasive malignancy within the past 3 years, except nonmelanomatous skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
  • No severe, active co-morbidity, including any of the following:
    • Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
    • Transmural myocardial infarction within the past 6 months
    • Acute bacterial or fungal infection requiring IV antibiotics at the time of study entry
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study entry
    • Coagulation defects
  • No prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin
    • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • No prior systemic chemotherapy for the current cervical cancer
    • Prior chemotherapy for a different cancer is allowed
  • No prior radiotherapy to the pelvis that would result in overlap of radiotherapy fields

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (125)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
McGill University Department of Oncology
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Pamela Youde Nethersole Eastern Hospital
Coordinator of this site? Confirm its status
Chai WanHong Kong SAR ChinaUnknown status
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
SeongnamSouth KoreaUnknown status
Korea Cancer Center Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Gangnam Severance Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Hickman Cancer Center
Coordinator of this site? Confirm its status
AdrianUnited StatesUnknown status
Summa Akron City Hospital/Cooper Cancer Center
Coordinator of this site? Confirm its status
AkronUnited StatesUnknown status
Akron General Medical Center
Coordinator of this site? Confirm its status
AkronUnited StatesUnknown status
Providence Alaska Medical Center
Coordinator of this site? Confirm its status
AnchorageUnited StatesUnknown status
Saint Vincent Anderson Regional Hospital/Cancer Center
Coordinator of this site? Confirm its status
AndersonUnited StatesUnknown status
Northside Hospital
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Grady Health System
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Maryland/Greenebaum Cancer Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Sinai Hospital of Baltimore
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Greater Baltimore Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Summa Barberton Hospital
Coordinator of this site? Confirm its status
BarbertonUnited StatesUnknown status
Saint Francis Hospital and Health Centers
Coordinator of this site? Confirm its status
Beech GroveUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
Saint Alphonsus Regional Medical Center
Coordinator of this site? Confirm its status
BoiseUnited StatesUnknown status
State University of New York Downstate Medical Center
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Coordinator of this site? Confirm its status
BurbankUnited StatesUnknown status
Cooper Hospital University Medical Center
Coordinator of this site? Confirm its status
CamdenUnited StatesUnknown status
Mercy San Juan Medical Center
Coordinator of this site? Confirm its status
CarmichaelUnited StatesUnknown status
Carolinas Medical Center
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Rush University Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Northwestern University
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
University of Cincinnati
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Case Western Reserve University
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Penrose-Saint Francis Healthcare
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesUnknown status
Central Maryland Radiation Oncology in Howard County
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach
Coordinator of this site? Confirm its status
Deerfield BeachUnited StatesUnknown status
Saint John Hospital and Medical Center
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Delaware County Memorial Hospital
Coordinator of this site? Confirm its status
Drexel HillUnited StatesUnknown status
City of Hope Medical Center
Coordinator of this site? Confirm its status
DuarteUnited StatesUnknown status
Northeast Georgia Medical Center
Coordinator of this site? Confirm its status
GainesvilleUnited StatesUnknown status
Saint Vincent Hospital
Coordinator of this site? Confirm its status
Green BayUnited StatesUnknown status
Franciscan Saint Margaret Health-Hammond Campus
Coordinator of this site? Confirm its status
HammondUnited StatesUnknown status
Hartford Hospital
Coordinator of this site? Confirm its status
HartfordUnited StatesUnknown status
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Coordinator of this site? Confirm its status
HollywoodUnited StatesUnknown status
Queen's Medical Center
Coordinator of this site? Confirm its status
HonoluluUnited StatesUnknown status
University of Hawaii
Coordinator of this site? Confirm its status
HonoluluUnited StatesUnknown status
Methodist Hospital
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Franciscan Saint Francis Health-Indianapolis
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
University of Iowa Hospitals and Clinics
Coordinator of this site? Confirm its status
Iowa CityUnited StatesUnknown status
University of Mississippi Medical Center
Coordinator of this site? Confirm its status
JacksonUnited StatesUnknown status
West Michigan Cancer Center
Coordinator of this site? Confirm its status
KalamazooUnited StatesUnknown status
Kansas City Cancer Centers - North
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Kansas City Cancer Center - South
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
University of Kansas Medical Center
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
University of Tennessee - Knoxville
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
Kansas City Cancer Center-Lee's Summit
Coordinator of this site? Confirm its status
Lee's SummitUnited StatesUnknown status
Elliot Hospital
Coordinator of this site? Confirm its status
ManchesterUnited StatesUnknown status
Mercy Medical Center - North Iowa
Coordinator of this site? Confirm its status
Mason CityUnited StatesUnknown status
Summa Health Center at Lake Medina
Coordinator of this site? Confirm its status
MedinaUnited StatesUnknown status
University of Miami Miller School of Medicine-Sylvester Cancer Center
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Jackson Memorial Hospital-Holtz Children's Hospital
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Baptist Hospital of Miami
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Aurora Saint Luke's Medical Center
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Froedtert and the Medical College of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Abbott-Northwestern Hospital
Coordinator of this site? Confirm its status
MinneapolisUnited StatesUnknown status
Michiana Hematology Oncology PC-Mishawaka
Coordinator of this site? Confirm its status
MishawakaUnited StatesUnknown status
Providence Hospital
Coordinator of this site? Confirm its status
MobileUnited StatesUnknown status
Morristown Memorial Hospital
Coordinator of this site? Confirm its status
MorristownUnited StatesUnknown status
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Coordinator of this site? Confirm its status
Mount HollyUnited StatesUnknown status
Intermountain Medical Center
Coordinator of this site? Confirm its status
MurrayUnited StatesUnknown status
UMDNJ - New Jersey Medical School
Coordinator of this site? Confirm its status
NewarkUnited StatesUnknown status
The Hospital of Central Connecticut
Coordinator of this site? Confirm its status
New BritainUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
McKay-Dee Hospital Center
Coordinator of this site? Confirm its status
OgdenUnited StatesUnknown status
University of Oklahoma Health Sciences Center
Coordinator of this site? Confirm its status
Oklahoma CityUnited StatesUnknown status
Nebraska Methodist Hospital
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
The Nebraska Medical Center
Coordinator of this site? Confirm its status
OmahaUnited StatesUnknown status
UHHS-Chagrin Highlands Medical Center
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Saint Joseph Hospital - Orange
Coordinator of this site? Confirm its status
OrangeUnited StatesUnknown status
Florida Hospital
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Kansas City Cancer Centers - Southwest
Coordinator of this site? Confirm its status
Overland ParkUnited StatesUnknown status
OSF Saint Francis Medical Center
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Arizona Center for Cancer Care-Peoria
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Saint Joseph's Hospital and Medical Center
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Pomona Valley Hospital Medical Center
Coordinator of this site? Confirm its status
PomonaUnited StatesUnknown status
Saint Joseph Mercy Port Huron
Coordinator of this site? Confirm its status
Port HuronUnited StatesUnknown status
Providence Portland Medical Center
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Providence Saint Vincent Medical Center
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Southern Ohio Medical Center
Coordinator of this site? Confirm its status
PortsmouthUnited StatesUnknown status
Women and Infants Hospital
Coordinator of this site? Confirm its status
ProvidenceUnited StatesUnknown status
Rapid City Regional Hospital
Coordinator of this site? Confirm its status
Rapid CityUnited StatesUnknown status
Robinson Radiation Oncology
Coordinator of this site? Confirm its status
RavennaUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
University of Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Highland Hospital
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
Phelps County Regional Medical Center
Coordinator of this site? Confirm its status
RollaUnited StatesUnknown status
Mercy General Hospital Radiation Oncology Center
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Mercy Cancer Center
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Cancer Care Center, Incorporated
Coordinator of this site? Confirm its status
SalemUnited StatesUnknown status
Huntsman Cancer Institute/University of Utah
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesUnknown status
University of California At San Diego
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
Ireland Cancer Center at Firelands Regional Medical Center
Coordinator of this site? Confirm its status
SanduskyUnited StatesUnknown status
Memorial Health University Medical Center
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Saint Joseph's-Candler Health System
Coordinator of this site? Confirm its status
SavannahUnited StatesUnknown status
Seattle Cancer Care Alliance
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Holy Cross Hospital
Coordinator of this site? Confirm its status
Silver SpringUnited StatesUnknown status
Sanford Cancer Center Oncology Clinic
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesUnknown status
CoxHealth South Hospital
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Mercy Hospital Springfield
Coordinator of this site? Confirm its status
SpringfieldUnited StatesUnknown status
Dixie Medical Center Regional Cancer Center
Coordinator of this site? Confirm its status
St. GeorgeUnited StatesUnknown status
Saint Helena Hospital
Coordinator of this site? Confirm its status
St. HelenaUnited StatesUnknown status
Saint John's Mercy Medical Center
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Flower Hospital
Coordinator of this site? Confirm its status
SylvaniaUnited StatesUnknown status
Montefiore Medical Center-Weiler Division
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
Montefiore Medical Center
Coordinator of this site? Confirm its status
The BronxUnited StatesUnknown status
University of Toledo
Coordinator of this site? Confirm its status
ToledoUnited StatesUnknown status
MD Anderson Cancer Center at Cooper-Voorhees
Coordinator of this site? Confirm its status
Voorhees TownshipUnited StatesUnknown status
Saint John Macomb-Oakland Hospital
Coordinator of this site? Confirm its status
WarrenUnited StatesUnknown status
Aurora West Allis Medical Center
Coordinator of this site? Confirm its status
West AllisUnited StatesUnknown status
UHHS-Westlake Medical Center
Coordinator of this site? Confirm its status
WestlakeUnited StatesUnknown status
Reading Hospital
Coordinator of this site? Confirm its status
West ReadingUnited StatesUnknown status
Wheeling Hospital
Coordinator of this site? Confirm its status
WheelingUnited StatesUnknown status
Via Christi Regional Medical Center
Coordinator of this site? Confirm its status
WichitaUnited StatesUnknown status
Cancer Treatment Center
Coordinator of this site? Confirm its status
WoosterUnited StatesUnknown status
Lankenau Hospital
Coordinator of this site? Confirm its status
WynnewoodUnited StatesUnknown status
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Coordinator of this site? Confirm its status
YakimaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.