Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IA cervical cancer, stage IB cervical cancer, stage IIA cervical cancer
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: carboplatin Type: Drug
Name: cisplatin Type: Drug
Name: paclitaxel Type: Drug
Overall Status
Recruiting
Summary
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.
Detailed Description
OBJECTIVES:

Primary

- To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.

Secondary

- To evaluate adverse events.

- To evaluate overall survival.

- To evaluate quality of life.

- To evaluate chemotherapy-induced neuropathy.

- To perform a post-hoc dose-volume evaluation between patients treated with standard radiotherapy and patients treated with intensity-modulated radiotherapy (IMRT) with respect to toxicity and local control.

- To collect fixed tissue samples to identify tumor molecular signatures that may be associated with patient outcomes, such as adverse events, disease-free survival, and overall survival.

- To collect blood samples to identify secreted factors from serum and plasma that may be associated with adverse events or outcome and to identify single nucleotide polymorphisms (SNPs) in genes from buffy coat that may be associated with a genetic predisposition to tumor formation itself or a response to cytotoxic therapy.

OUTLINE: This is a multicenter study. Patients are stratified according to planned use of brachytherapy (no vs. yes), radiotherapy modality - [standard external beam radiotherapy (EBRT) vs. intensity-modulated radiotherapy (IMRT)], and radiotherapy dose (45 Gy vs. 50.4 Gy). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo standard EBRT or IMRT to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin IV over 1 hour once weekly for 6 weeks.

NOTE: Some patients may also undergo brachytherapy beginning within 7 days after completion of radiotherapy.

- Arm II: Patients receive chemoradiotherapy as in arm I. Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed by the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group (FACT-GOG/NTX4), FACT-Cx, and FACIT-D questionnaires at baseline; at the completion of chemoradiotherapy; and then at 6, 12, and 24 months after completion of chemoradiotherapy.

Blood and tissue samples may be collected for gene expression analysis by immuno-histochemistry (IHC) and for biomarker and polymorphism studies.

After completion of study treatment, patients are followed up very 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: 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 PET/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
Locations
University of Alabama at Birmingham
Birmingham, Alabama, United States
Status: Active, not recruiting
Providence Hospital
Mobile, Alabama, United States
Status: Terminated
Providence Alaska Medical Center
Anchorage, Alaska, United States
Status: Active, not recruiting
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States
Status: Active, not recruiting
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Status: Active, not recruiting
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Status: Active, not recruiting
Roy and Patricia Disney Family Cancer Center
Burbank, California, United States
Status: Withdrawn
City of Hope Medical Center
Duarte, California, United States
Status: Active, not recruiting
Saint Joseph Hospital - Orange
Orange, California, United States
Status: Active, not recruiting
Pomona Valley Hospital Medical Center
Pomona, California, United States
Status: Active, not recruiting
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States
Status: Terminated
Radiological Associates of Sacramento
Sacramento, California, United States
Status: Withdrawn
Saint Helena Hospital
Saint Helena, California, United States
Status: Active, not recruiting
University of California At San Diego
San Diego, California, United States
Status: Active, not recruiting
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Status: Withdrawn
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Status: Active, not recruiting
Hartford Hospital
Hartford, Connecticut, United States
Status: Active, not recruiting
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Status: Active, not recruiting
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States
Status: Active, not recruiting
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Status: Active, not recruiting
Baptist Hospital of Miami
Miami, Florida, United States
Status: Active, not recruiting
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States
Status: Active, not recruiting
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States
Status: Active, not recruiting
Florida Hospital
Orlando, Florida, United States
Status: Active, not recruiting
Grady Health System
Atlanta, Georgia, United States
Status: Active, not recruiting
Northside Hospital
Atlanta, Georgia, United States
Status: Active, not recruiting
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Status: Active, not recruiting
Memorial Health University Medical Center
Savannah, Georgia, United States
Status: Active, not recruiting
Saint Joseph's-Candler Health System
Savannah, Georgia, United States
Status: Active, not recruiting
Queen's Medical Center
Honolulu, Hawaii, United States
Status: Active, not recruiting
University of Hawaii
Honolulu, Hawaii, United States
Status: Active, not recruiting
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Status: Active, not recruiting
Northwestern University
Chicago, Illinois, United States
Status: Active, not recruiting
Rush University Medical Center
Chicago, Illinois, United States
Status: Active, not recruiting
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Status: Active, not recruiting
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States
Status: Active, not recruiting
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States
Status: Recruiting
Contact: David H. Moore - 317-851-2555
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, United States
Status: Terminated
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States
Status: Active, not recruiting
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Status: Active, not recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Status: Active, not recruiting
Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Status: Active, not recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States
Status: Active, not recruiting
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Status: Active, not recruiting
Via Christi Regional Medical Center
Wichita, Kansas, United States
Status: Active, not recruiting
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Status: Active, not recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Status: Active, not recruiting
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Status: Active, not recruiting
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States
Status: Active, not recruiting
Holy Cross Hospital
Silver Spring, Maryland, United States
Status: Active, not recruiting
Hickman Cancer Center
Adrian, Michigan, United States
Status: Active, not recruiting
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Status: Active, not recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States
Status: Withdrawn
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Status: Active, not recruiting
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Status: Active, not recruiting
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Status: Active, not recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Status: Active, not recruiting
Mayo Clinic
Rochester, Minnesota, United States
Status: Active, not recruiting
University of Mississippi Medical Center
Jackson, Mississippi, United States
Status: Active, not recruiting
Kansas City Cancer Center - South
Kansas City, Missouri, United States
Status: Active, not recruiting
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Status: Active, not recruiting
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States
Status: Active, not recruiting
Phelps County Regional Medical Center
Rolla, Missouri, United States
Status: Active, not recruiting
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States
Status: Active, not recruiting
CoxHealth South Hospital
Springfield, Missouri, United States
Status: Active, not recruiting
Mercy Hospital Springfield
Springfield, Missouri, United States
Status: Active, not recruiting
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Status: Active, not recruiting
The Nebraska Medical Center
Omaha, Nebraska, United States
Status: Active, not recruiting
Elliot Hospital
Manchester, New Hampshire, United States
Status: Active, not recruiting
Cooper Hospital University Medical Center
Camden, New Jersey, United States
Status: Active, not recruiting
Morristown Memorial Hospital
Morristown, New Jersey, United States
Status: Active, not recruiting
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States
Status: Active, not recruiting
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States
Status: Active, not recruiting
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey, United States
Status: Active, not recruiting
Montefiore Medical Center
Bronx, New York, United States
Status: Active, not recruiting
Montefiore Medical Center-Weiler Division
Bronx, New York, United States
Status: Active, not recruiting
State University of New York Downstate Medical Center
Brooklyn, New York, United States
Status: Active, not recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Status: Active, not recruiting
Highland Hospital
Rochester, New York, United States
Status: Active, not recruiting
University of Rochester
Rochester, New York, United States
Status: Active, not recruiting
Carolinas Medical Center
Charlotte, North Carolina, United States
Status: Active, not recruiting
Akron General Medical Center
Akron, Ohio, United States
Status: Active, not recruiting
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States
Status: Active, not recruiting
Summa Barberton Hospital
Barberton, Ohio, United States
Status: Active, not recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Status: Active, not recruiting
Case Western Reserve University
Cleveland, Ohio, United States
Status: Active, not recruiting
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States
Status: Active, not recruiting
Summa Health Center at Lake Medina
Medina, Ohio, United States
Status: Active, not recruiting
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States
Status: Active, not recruiting
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Status: Active, not recruiting
Robinson Radiation Oncology
Ravenna, Ohio, United States
Status: Active, not recruiting
Cancer Care Center, Incorporated
Salem, Ohio, United States
Status: Terminated
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States
Status: Active, not recruiting
Flower Hospital
Sylvania, Ohio, United States
Status: Active, not recruiting
University of Toledo
Toledo, Ohio, United States
Status: Active, not recruiting
UHHS-Westlake Medical Center
Westlake, Ohio, United States
Status: Active, not recruiting
Cancer Treatment Center
Wooster, Ohio, United States
Status: Terminated
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Status: Active, not recruiting
Natalie Warren Bryant Cancer Center at Saint Francis
Tulsa, Oklahoma, United States
Status: Withdrawn
Providence Portland Medical Center
Portland, Oregon, United States
Status: Active, not recruiting
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Status: Active, not recruiting
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Status: Active, not recruiting
Reading Hospital
West Reading, Pennsylvania, United States
Status: Active, not recruiting
Lankenau Hospital
Wynnewood, Pennsylvania, United States
Status: Recruiting
Contact: Paul B. Gilman - 484-476-2649 - wellenbachj@mlhs.org
Women and Infants Hospital
Providence, Rhode Island, United States
Status: Active, not recruiting
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Status: Active, not recruiting
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States
Status: Recruiting
Contact: Miroslaw A. Mazurczak - 605-328-1367
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
Status: Active, not recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Status: Active, not recruiting
M D Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Contact: Ann H. Klopp - aklopp@mdanderson.org
M D Anderson Cancer Center
Houston, Texas, United States
Status: Active, not recruiting
Methodist Hospital
Houston, Texas, United States
Status: Active, not recruiting
Intermountain Medical Center
Murray, Utah, United States
Status: Active, not recruiting
McKay-Dee Hospital Center
Ogden, Utah, United States
Status: Active, not recruiting
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States
Status: Active, not recruiting
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Status: Active, not recruiting
Seattle Cancer Care Alliance
Seattle, Washington, United States
Status: Active, not recruiting
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Status: Recruiting
Contact: Sean F. Cleary - 877-902-3324
Wheeling Hospital
Wheeling, West Virginia, United States
Status: Active, not recruiting
Saint Vincent Hospital
Green Bay, Wisconsin, United States
Status: Active, not recruiting
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Status: Active, not recruiting
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Status: Active, not recruiting
Aurora West Allis Medical Center
West Allis, Wisconsin, United States
Status: Active, not recruiting
McGill University Department of Oncology
Montreal, Quebec, Canada
Status: Active, not recruiting
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Status: Active, not recruiting
Seoul National University Bundang Hospital
Seongnam City, Kyeonggi-do, Korea, Republic of
Status: Active, not recruiting
Gangnam Severance Hospital
Seoul, Korea, Republic of
Status: Active, not recruiting
Korea Cancer Center Hospital
Seoul, Korea, Republic of
Status: Active, not recruiting
Seoul National University Hospital
Seoul, Korea, Republic of
Status: Active, not recruiting
Start Date
September 2009
Sponsors
Radiation Therapy Oncology Group
Source
Radiation Therapy Oncology Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page