Trial record 1 of 1 for:    RTOG 0724
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Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00980954
First received: September 18, 2009
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Cervical Cancer
Drug: carboplatin
Drug: cisplatin
Drug: paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: From randomization to date of first failure (local, regional, or distant metastases failure or death due to any cause) or last follow-up. Analysis occurs after 43 disease-free survival failure events on Cisplatin/RT Arm. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 4 years. ] [ Designated as safety issue: No ]
  • Chemotherapy-induced neuropathy as measured by FACT-GOG/NTX4 [ Time Frame: From completion of concurrent chemoradiation to 12 months. ] [ Designated as safety issue: No ]
  • Quality of life as measured by FACT-Cx and FACIT-D [ Time Frame: From completion of concurrent chemoradiation to 12 months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2009
Estimated Primary Completion Date: August 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I: Cisplatin/Radiation Therapy
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.
Drug: cisplatin
Given IV
Experimental: Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
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.
Drug: carboplatin
Given IV
Drug: cisplatin
Given IV
Drug: paclitaxel
Given IV

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980954

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, United States, 85381
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
City of Hope Medical Center
Duarte, California, United States, 91010
Saint Joseph Hospital - Orange
Orange, California, United States, 92868
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
Mercy General Hospital Radiation Oncology Center
Sacramento, California, United States, 95819
Saint Helena Hospital
Saint Helena, California, United States, 94574
University of California At San Diego
San Diego, California, United States, 92103
United States, Colorado
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06102
The Hospital of Central Connecticut
New Britain, Connecticut, United States, 06050
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, United States, 33442
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Baptist Hospital of Miami
Miami, Florida, United States, 33176
Jackson Memorial Hospital-Holtz Children's Hospital
Miami, Florida, United States, 33136
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Grady Health System
Atlanta, Georgia, United States, 30303
Northside Hospital
Atlanta, Georgia, United States, 30342
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
United States, Indiana
Saint Vincent Anderson Regional Hospital/Cancer Center
Anderson, Indiana, United States, 46016
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Franciscan Saint Margaret Health-Hammond Campus
Hammond, Indiana, United States, 46320
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States, 46237
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, United States, 21044
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New Hampshire
Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Montefiore Medical Center-Weiler Division
Bronx, New York, United States, 10461
Montefiore Medical Center
Bronx, New York, United States, 10467-2490
State University of New York Downstate Medical Center
Brooklyn, New York, United States, 11203
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Highland Hospital
Rochester, New York, United States, 14620
University of Rochester
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, United States, 44304
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Summa Health Center at Lake Medina
Medina, Ohio, United States, 44256
UHHS-Chagrin Highlands Medical Center
Orange Village, Ohio, United States, 44122
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Robinson Radiation Oncology
Ravenna, Ohio, United States, 44266
Cancer Care Center, Incorporated
Salem, Ohio, United States, 44460
Ireland Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
University of Toledo
Toledo, Ohio, United States, 43614
UHHS-Westlake Medical Center
Westlake, Ohio, United States, 44145
Cancer Treatment Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
United States, Pennsylvania
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Reading Hospital
West Reading, Pennsylvania, United States, 19611
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Wheeling Hospital
Wheeling, West Virginia, United States, 26003
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
Canada, Quebec
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Chai Wan, Hong Kong
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam City, Kyeonggi-do, Korea, Republic of, 463-707
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Korea Cancer Center Hospital
Seoul, Korea, Republic of, 139-706
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Principal Investigator: Anuja Jhingran, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00980954     History of Changes
Other Study ID Numbers: RTOG 0724, CDR0000654709, NCI-2011-01973
Study First Received: September 18, 2009
Last Updated: May 29, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical squamous cell carcinoma
stage IA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carboplatin
Paclitaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014