Cervical cancer trial: does extra chemo after surgery help?

NCT ID NCT00980954

Disease control Sponsor: Radiation Therapy Oncology Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial studied 236 women with high-risk early-stage cervical cancer who had already undergone a radical hysterectomy. Researchers compared standard chemoradiation (cisplatin plus pelvic radiation) with the same treatment followed by additional chemotherapy (paclitaxel and carboplatin). The goal was to see if the extra chemo improved disease-free survival. The study is complete, and results will help determine if the added chemotherapy provides any benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: cisplatin, paclitaxel, carboplatin (chemotherapy) and radiation therapy
What this could lead to: If successful, this could confirm that adding extra chemotherapy after standard chemoradiation improves disease-free survival for high-risk cervical cancer patients.
What could go wrong: This trial is completed and results may show no significant benefit from the extra chemotherapy. It is a phase 3 study, but the findings may not apply to all patients or change standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

236 people

The number who actually took part.

Start date

Sep 2009

Finished

Sep 2025

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

cervical cancer cervical carcinoma Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical cancer

Contacts and locations

Locations

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407, United States
Akron General Medical Center

Akron, Ohio, 44307, United States
Arizona Center for Cancer Care-Peoria

Peoria, Arizona, 85381, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States
Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States
Aurora West Allis Medical Center

West Allis, Wisconsin, 53227, United States
Baptist Hospital of Miami

Miami, Florida, 33176, United States
Cancer Care Center, Incorporated

Salem, Ohio, 44460, United States
Cancer Treatment Center

Wooster, Ohio, 44691, United States
Carolinas Medical Center

Charlotte, North Carolina, 28203, United States
Case Western Reserve University

Cleveland, Ohio, 44106, United States
Central Maryland Radiation Oncology in Howard County

Columbia, Maryland, 21044, United States
City of Hope Medical Center

Duarte, California, 91010, United States
Cooper Hospital University Medical Center

Camden, New Jersey, 08103, United States
CoxHealth South Hospital

Springfield, Missouri, 65807, United States
Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026, United States
Dixie Medical Center Regional Cancer Center

St. George, Utah, 84770, United States
Elliot Hospital

Manchester, New Hampshire, 03103, United States
Florida Hospital

Orlando, Florida, 32803, United States
Flower Hospital

Sylvania, Ohio, 43560, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Mount Holly, New Jersey, 08060, United States
Franciscan Saint Francis Health-Indianapolis

Indianapolis, Indiana, 46237, United States
Franciscan Saint Margaret Health-Hammond Campus

Hammond, Indiana, 46320, United States
Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Gangnam Severance Hospital

Seoul, 135-720, South Korea
Grady Health System

Atlanta, Georgia, 30303, United States
Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Hickman Cancer Center

Adrian, Michigan, 49221, United States
Highland Hospital

Rochester, New York, 14620, United States
Holy Cross Hospital

Silver Spring, Maryland, 20910, United States
Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States
Intermountain Medical Center

Murray, Utah, 84157, United States
Ireland Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States
Jackson Memorial Hospital-Holtz Children's Hospital

Miami, Florida, 33136, United States
Kansas City Cancer Center - South

Kansas City, Missouri, 64131, United States
Kansas City Cancer Center-Lee's Summit

Lee's Summit, Missouri, 64064, United States
Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States
Kansas City Cancer Centers-Southwest

Overland Park, Kansas, 66210, United States
Korea Cancer Center Hospital

Seoul, 139-706, South Korea
Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States
M D Anderson Cancer Center

Houston, Texas, 77030, United States
MD Anderson Cancer Center at Cooper-Voorhees

Voorhees Township, New Jersey, 08043, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
McGill University Department of Oncology

Montreal, Quebec, H2W 1S6, Canada
McKay-Dee Hospital Center

Ogden, Utah, 84403, United States
Memorial Health University Medical Center

Savannah, Georgia, 31403, United States
Memorial Healthcare System - Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States
Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States
Mercy Cancer Center

Sacramento, California, 95816, United States
Mercy General Hospital Radiation Oncology Center

Sacramento, California, 95819, United States
Mercy Hospital Springfield

Springfield, Missouri, 65804, United States
Mercy Medical Center - North Iowa

Mason City, Iowa, 50401, United States
Mercy San Juan Medical Center

Carmichael, California, 95608, United States
Methodist Hospital

Houston, Texas, 77030, United States
Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, 46545-1470, United States
Montefiore Medical Center

The Bronx, New York, 10467-2490, United States
Montefiore Medical Center-Weiler Division

The Bronx, New York, 10461, United States
Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States
Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902, United States
Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States
Northside Hospital

Atlanta, Georgia, 30342, United States
Northwestern University

Chicago, Illinois, 60611, United States
OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States
Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong
Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States
Phelps County Regional Medical Center

Rolla, Missouri, 65401, United States
Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States
Providence Alaska Medical Center

Anchorage, Alaska, 99508, United States
Providence Hospital

Mobile, Alabama, 36608, United States
Providence Portland Medical Center

Portland, Oregon, 97213, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505, United States
Providence Saint Vincent Medical Center

Portland, Oregon, 97225, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Robinson Radiation Oncology

Ravenna, Ohio, 44266, United States
Rush University Medical Center

Chicago, Illinois, 60612, United States
Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706, United States
Saint Francis Hospital and Health Centers

Beech Grove, Indiana, 46107, United States
Saint Helena Hospital

St. Helena, California, 94574, United States
Saint John Hospital and Medical Center

Detroit, Michigan, 48236, United States
Saint John Macomb-Oakland Hospital

Warren, Michigan, 48093, United States
Saint John's Mercy Medical Center

St Louis, Missouri, 63141, United States
Saint Joseph Hospital - Orange

Orange, California, 92868, United States
Saint Joseph Mercy Port Huron

Port Huron, Michigan, 48060, United States
Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States
Saint Joseph's-Candler Health System

Savannah, Georgia, 31405, United States
Saint Vincent Anderson Regional Hospital/Cancer Center

Anderson, Indiana, 46016, United States
Saint Vincent Hospital

Green Bay, Wisconsin, 54301, United States
Sanford Cancer Center-Oncology Clinic

Sioux Falls, South Dakota, 57104, United States
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Seoul National University Bundang Hospital

Seongnam, Kyeonggi-do, 463-707, South Korea
Seoul National University Hospital

Seoul, 110-744, South Korea
Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States
Southern Ohio Medical Center

Portsmouth, Ohio, 45662, United States
State University of New York Downstate Medical Center

Brooklyn, New York, 11203, United States
Summa Akron City Hospital/Cooper Cancer Center

Akron, Ohio, 44304, United States
Summa Barberton Hospital

Barberton, Ohio, 44203, United States
Summa Health Center at Lake Medina

Medina, Ohio, 44256, United States
The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States
The Nebraska Medical Center

Omaha, Nebraska, 68198, United States
UHHS-Chagrin Highlands Medical Center

Orange, Ohio, 44122, United States
UHHS-Westlake Medical Center

Westlake, Ohio, 44145, United States
UMDNJ - New Jersey Medical School

Newark, New Jersey, 07103, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of California At San Diego

San Diego, California, 92103, United States
University of Cincinnati

Cincinnati, Ohio, 45267, United States
University of Hawaii

Honolulu, Hawaii, 96813, United States
University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States
University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Rochester

Rochester, New York, 14642, United States
University of Tennessee - Knoxville

Knoxville, Tennessee, 37920, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
University of Toledo

Toledo, Ohio, 43614, United States
Via Christi Regional Medical Center

Wichita, Kansas, 67214, United States
West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States
Wheeling Hospital

Wheeling, West Virginia, 26003, United States
Women and Infants Hospital

Providence, Rhode Island, 02905, United States

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