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
- Diseases
- Cervical cancer
- 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
Sites (125)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Department of Oncology Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Pamela Youde Nethersole Eastern Hospital Coordinator of this site? Confirm its status | Chai Wan | Hong Kong SAR China | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Korea Cancer Center Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hickman Cancer Center Coordinator of this site? Confirm its status | Adrian | United States | Unknown status |
| Summa Akron City Hospital/Cooper Cancer Center Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Akron General Medical Center Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Providence Alaska Medical Center Coordinator of this site? Confirm its status | Anchorage | United States | Unknown status |
| Saint Vincent Anderson Regional Hospital/Cancer Center Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Northside Hospital Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Grady Health System Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Maryland/Greenebaum Cancer Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Sinai Hospital of Baltimore Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Greater Baltimore Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Summa Barberton Hospital Coordinator of this site? Confirm its status | Barberton | United States | Unknown status |
| Saint Francis Hospital and Health Centers Coordinator of this site? Confirm its status | Beech Grove | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Saint Alphonsus Regional Medical Center Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| State University of New York Downstate Medical Center Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Providence Saint Joseph Medical Center/Disney Family Cancer Center Coordinator of this site? Confirm its status | Burbank | United States | Unknown status |
| Cooper Hospital University Medical Center Coordinator of this site? Confirm its status | Camden | United States | Unknown status |
| Mercy San Juan Medical Center Coordinator of this site? Confirm its status | Carmichael | United States | Unknown status |
| Carolinas Medical Center Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Rush University Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Case Western Reserve University Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Penrose-Saint Francis Healthcare Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Central Maryland Radiation Oncology in Howard County Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Saint John Hospital and Medical Center Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Delaware County Memorial Hospital Coordinator of this site? Confirm its status | Drexel Hill | United States | Unknown status |
| City of Hope Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| Northeast Georgia Medical Center Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Saint Vincent Hospital Coordinator of this site? Confirm its status | Green Bay | United States | Unknown status |
| Franciscan Saint Margaret Health-Hammond Campus Coordinator of this site? Confirm its status | Hammond | United States | Unknown status |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Memorial Healthcare System - Joe DiMaggio Children's Hospital Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Queen's Medical Center Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| University of Hawaii Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Franciscan Saint Francis Health-Indianapolis Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Iowa Hospitals and Clinics Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| University of Mississippi Medical Center Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| West Michigan Cancer Center Coordinator of this site? Confirm its status | Kalamazoo | United States | Unknown status |
| Kansas City Cancer Centers - North Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Kansas City Cancer Center - South Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Tennessee - Knoxville Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| Kansas City Cancer Center-Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Unknown status |
| Elliot Hospital Coordinator of this site? Confirm its status | Manchester | United States | Unknown status |
| Mercy Medical Center - North Iowa Coordinator of this site? Confirm its status | Mason City | United States | Unknown status |
| Summa Health Center at Lake Medina Coordinator of this site? Confirm its status | Medina | United States | Unknown status |
| University of Miami Miller School of Medicine-Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Jackson Memorial Hospital-Holtz Children's Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Baptist Hospital of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Aurora Saint Luke's Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Froedtert and the Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Abbott-Northwestern Hospital Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Michiana Hematology Oncology PC-Mishawaka Coordinator of this site? Confirm its status | Mishawaka | United States | Unknown status |
| Providence Hospital Coordinator of this site? Confirm its status | Mobile | United States | Unknown status |
| Morristown Memorial Hospital Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County Coordinator of this site? Confirm its status | Mount Holly | United States | Unknown status |
| Intermountain Medical Center Coordinator of this site? Confirm its status | Murray | United States | Unknown status |
| UMDNJ - New Jersey Medical School Coordinator of this site? Confirm its status | Newark | United States | Unknown status |
| The Hospital of Central Connecticut Coordinator of this site? Confirm its status | New Britain | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| McKay-Dee Hospital Center Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Nebraska Methodist Hospital Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| The Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| UHHS-Chagrin Highlands Medical Center Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Saint Joseph Hospital - Orange Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Florida Hospital Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Kansas City Cancer Centers - Southwest Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| OSF Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Arizona Center for Cancer Care-Peoria Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Saint Joseph's Hospital and Medical Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Pomona Valley Hospital Medical Center Coordinator of this site? Confirm its status | Pomona | United States | Unknown status |
| Saint Joseph Mercy Port Huron Coordinator of this site? Confirm its status | Port Huron | United States | Unknown status |
| Providence Portland Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Providence Saint Vincent Medical Center Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Southern Ohio Medical Center Coordinator of this site? Confirm its status | Portsmouth | United States | Unknown status |
| Women and Infants Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| Rapid City Regional Hospital Coordinator of this site? Confirm its status | Rapid City | United States | Unknown status |
| Robinson Radiation Oncology Coordinator of this site? Confirm its status | Ravenna | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Highland Hospital Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Phelps County Regional Medical Center Coordinator of this site? Confirm its status | Rolla | United States | Unknown status |
| Mercy General Hospital Radiation Oncology Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Mercy Cancer Center Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Cancer Care Center, Incorporated Coordinator of this site? Confirm its status | Salem | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of California At San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Ireland Cancer Center at Firelands Regional Medical Center Coordinator of this site? Confirm its status | Sandusky | United States | Unknown status |
| Memorial Health University Medical Center Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Saint Joseph's-Candler Health System Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Seattle Cancer Care Alliance Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Holy Cross Hospital Coordinator of this site? Confirm its status | Silver Spring | United States | Unknown status |
| Sanford Cancer Center Oncology Clinic Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| CoxHealth South Hospital Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Mercy Hospital Springfield Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Dixie Medical Center Regional Cancer Center Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Saint Helena Hospital Coordinator of this site? Confirm its status | St. Helena | United States | Unknown status |
| Saint John's Mercy Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Flower Hospital Coordinator of this site? Confirm its status | Sylvania | United States | Unknown status |
| Montefiore Medical Center-Weiler Division Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| University of Toledo Coordinator of this site? Confirm its status | Toledo | United States | Unknown status |
| MD Anderson Cancer Center at Cooper-Voorhees Coordinator of this site? Confirm its status | Voorhees Township | United States | Unknown status |
| Saint John Macomb-Oakland Hospital Coordinator of this site? Confirm its status | Warren | United States | Unknown status |
| Aurora West Allis Medical Center Coordinator of this site? Confirm its status | West Allis | United States | Unknown status |
| UHHS-Westlake Medical Center Coordinator of this site? Confirm its status | Westlake | United States | Unknown status |
| Reading Hospital Coordinator of this site? Confirm its status | West Reading | United States | Unknown status |
| Wheeling Hospital Coordinator of this site? Confirm its status | Wheeling | United States | Unknown status |
| Via Christi Regional Medical Center Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Cancer Treatment Center Coordinator of this site? Confirm its status | Wooster | United States | Unknown status |
| Lankenau Hospital Coordinator of this site? Confirm its status | Wynnewood | United States | Unknown status |
| North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Coordinator of this site? Confirm its status | Yakima | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.