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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overNCI, OtherRTOG 0724
CDR0000654709, NCI-2011-01973, NCT00980954

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Radiation Therapy Oncology Group

  • National Cancer Institute
Anuja Jhingran, Principal Investigator

Trial Sites

U.S.A.

Alaska
Anchorage

Providence Cancer Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Arizona
Phoenix

St. Joseph's Hospital and Medical Center

John H Farley
Ph: 877-602-4111

California
Burbank

Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

La Jolla

Rebecca and John Moores UCSD Cancer Center

Anuja Jhingran

Orange

St. Joseph Hospital Regional Cancer Center - Orange

Krishnansu S Tewari
Ph: 714-456-6191
Email: awallick@uci.edu

Pomona

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Yallapragada S. Rao
Ph: 909-865-9555

Sacramento

Sutter Cancer Center

Christopher Jones
Ph: 415-209-2686
Email: bernicl@sutterhealth.org

Saint Helena

Saint Helena Hospital

David J Tate
Ph: 707-967-3698

Colorado
Colorado Springs

Penrose Cancer Center at Penrose Hospital

Keren Sturtz
Ph: 888-785-6789

Florida
Deerfield Beach

University of Miami/Deerfield Beach

Aaron H Wolfson
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Kissimmee

Florida Hospital Kissimmee

Lee M. Zehngebot
Ph: 407-303-5623

Miami

Jackson Memorial Hospital

Aaron H Wolfson
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

University of Miami Sylvester Comprehensive Cancer Center - Miami

Aaron H Wolfson
Ph: 866-574-5124
Email: Sylvester@emergingmed.com

Orlando

Florida Hospital Cancer Institute at Florida Hospital Orlando

Lee M. Zehngebot
Ph: 407-303-5623

Georgia
Gainesville

Northeast Georgia Medical Center

Frank G. Lake
Ph: 770-219-8800
Email: cancerpatient.navigator@nghs.com

Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

James J Burke
Ph: 912-350-8568

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

John A Pablo
Ph: 800-622-6877

Idaho
Boise

Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

Samir Narayan
Ph: 734-712-4673

Illinois
Chicago

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Eric D Donnelly
Ph: 312-695-1301
Email: cancer@northwestern.edu

Decatur

Decatur Memorial Hospital Cancer Care Institute

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Peoria

Methodist Medical Center of Illinois

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

OSF St. Francis Medical Center

James L. Wade
Ph: 217-876-4740
Email: kcheek@dmhhs.org

Indiana
Beech Grove

St. Francis Hospital and Health Centers - Beech Grove Campus

David H Moore
Ph: 317-851-2555

Fort Wayne

Radiation Oncology Associates Southwest

Brian K Chang
Ph: 260-373-8888
Email: parkviewresearch@parkview.com

Mishawaka

Michiana Hematology-Oncology, PC - Mishawaka

Binh N Tran
Ph: 574-237-1328

South Bend

CCOP - Northern Indiana CR Consortium

Anuja Jhingran

Kansas
Kansas City

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Parvesh Kumar
Ph: 913-588-4709

Overland Park

Kansas City Cancer Centers - Southwest

Parvesh Kumar
Ph: 913-588-4709

Maryland
Baltimore

Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

Jeanette A. F. Linder
Ph: 410-601-6120
Email: pridgely@lifebridgehealth.org

Greater Baltimore Medical Center Cancer Center

Paul Celano
Ph: 443-849-3706

Silver Spring

Holy Cross Hospital

Sheela D Modin
Ph: 310-754-7552

Michigan
Detroit

Van Elslander Cancer Center at St. John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Port Huron

Mercy Regional Cancer Center at Mercy Hospital

Samir Narayan
Ph: 734-712-4673

Warren

St. John Macomb Hospital

Samir Narayan
Ph: 734-712-4673

Mississippi
Jackson

University of Mississippi Cancer Clinic

James Tate Thigpen
Ph: 601-815-6700

Missouri
Kansas City

Kansas City Cancer Centers - North

Parvesh Kumar
Ph: 913-588-4709

Kansas City Cancer Centers - South

Parvesh Kumar
Ph: 913-588-4709

Lee's Summit

Kansas City Cancer Centers - East

Parvesh Kumar
Ph: 913-588-4709

Rolla

Phelps County Regional Medical Center

Jay W Carlson
Ph: 800-821-7532

Saint Louis

David C. Pratt Cancer Center at St. John's Mercy

Jay W Carlson
Ph: 800-821-7532

Springfield

St. John's Regional Health Center

Jay W Carlson
Ph: 800-821-7532

Nebraska
Omaha

Methodist Estabrook Cancer Center

Tien-Shew W Huang
Ph: 402-354-5144

New Hampshire
Manchester

Elliot Regional Cancer Center at Elliot Hospital

Brian R Knab
Ph: 603-663-1800

New Jersey
Camden

Cancer Institute of New Jersey at Cooper University Hospital - Camden

Tamara A LaCouture
Ph: 856-325-6757

Morristown

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Yana P Goldberg
Ph: 973-971-5900

Mount Holly

Virtua Fox Chase Health Cancer Program at Virtua Memorial Hospital Burlington County

Lemuel S. Ariaratnam
Ph: 888-847-8823

Voorhees

Cancer Institute of New Jersey at Cooper - Voorhees

Tamara A LaCouture
Ph: 856-325-6757

New York
New York

Memorial Sloan-Kettering Cancer Center

Mario M Leitao
Ph: 212-639-7202

Rochester

Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester

Yuhchyau Chen
Ph: 585-275-5830

James P. Wilmot Cancer Center at University of Rochester Medical Center

Yuhchyau Chen
Ph: 585-275-5830

North Carolina
Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

Robert Victor Higgins
Ph: 704-355-2884

Winston-Salem

Wake Forest University Comprehensive Cancer Center

Samuel S. Lentz
Ph: 336-713-6771

Ohio
Akron

McDowell Cancer Center at Akron General Medical Center

Mitchell Lee Fromm
Ph: 330-344-6348

Summa Center for Cancer Care at Akron City Hospital

Charles A Kunos
Ph: 330-375-6101

Barberton

Barberton Citizens Hospital

Charles A Kunos
Ph: 330-375-6101

Columbus

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

Anuja Jhingran

Portsmouth

Southern Ohio Medical Center Cancer Center

J. Philip Kuebler
Ph: 614-488-2745
Email: sheree@columbusccop.org

Ravenna

Robinson Radiation Oncology

Mitchell Lee Fromm
Ph: 330-344-6348

Oklahoma
Oklahoma City

Stephenson Cancer Center at the University of Oklahoma

Terence S. Herman
Ph: 405-271-4272
Email: julie-traylor@ouhsc.edu

Oregon
Portland

Providence Cancer Center at Providence Portland Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Providence St. Vincent Medical Center

Matthew C Solhjem
Ph: 503-215-6412
Email: Julie.Cramer@providence.org

Pennsylvania
Danville

Geisinger Cancer Institute at Geisinger Health

Thomas J Gergel
Ph: 570-271-5251

Philadelphia

Fox Chase Cancer Center - Philadelphia

Stephanie A. King
Ph: 215-728-4790

West Reading

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Michael L Haas
Ph: 610-988-9323

Rhode Island
Providence

Women and Infants Hospital of Rhode Island

Paul A. DiSilvestro
Ph: 401-274-1122

South Carolina
Greenville

Cancer Centers of the Carolinas - Faris Road

David L Grisell
Ph: 864-241-6251

CCOP - Greenville

David L Grisell
Ph: 864-241-6251

Greer

Cancer Centers of the Carolinas - Greer Radiation Oncology

David L Grisell
Ph: 864-241-6251

South Dakota
Rapid City

Rapid City Regional Hospital

Michael J Swartz
Ph: 605-716-3982
Email: research@rcrh.org

Sioux Falls

Avera Cancer Institute

Luis A Rojas-Espaillat
Ph: 800-657-4377
Email: Jan.Healy@avera.org

Tennessee
Knoxville

U.T. Medical Center Cancer Institute

Larry C Kilgore
Ph: 865-544-9773

Texas
Houston

M. D. Anderson Cancer Center at University of Texas

Ann H Klopp
Email: aklopp@mdanderson.org

Methodist Hospital

Aparna A Kamat
Ph: 713-790-2700

Univeristy of Texas M.D. Anderson Cancer Center

Ann H Klopp
Ph: 713-792-3245

Utah
Logan

Logan Regional Hospital

Anuja Jhingran

Murray

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

Ogden

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

R. Jeffrey Lee
Ph: 801-507-3950

Saint George

Dixie Regional Medical Center - East Campus

R. Jeffrey Lee
Ph: 801-507-3950

Salt Lake City

Huntsman Cancer Institute at University of Utah

David K. Gaffney
Ph: 801-581-4477
Email: clinical.trials@hci.utah.edu

Washington
Seattle

Seattle Cancer Care Alliance

Heidi J Gray
Ph: 206-616-8289

Yakima

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Sean F. Cleary
Ph: 877-902-3324

West Virginia
Wheeling

Schiffler Cancer Center at Wheeling Hospital

Jon David Pollock
Ph: 304-243-6442

Wisconsin
Green Bay

St. Vincent Hospital Regional Cancer Center

James L Leenstra
Ph: 920-433-8889

La Crosse

Gundersen Lutheran Center for Cancer and Blood

Collin D Driscoll
Ph: 608-775-2385
Email: cancerctr@gundluth.org

Milwaukee

Froedtert Hospital and Medical College of Wisconsin

Beth Ann Erickson
Ph: 414-805-4380

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

West Allis

Aurora Women's Pavilion of West Allis Memorial Hospital

Ali Mahdavi
Ph: 414-649-5717

Canada

Quebec
Montreal

McGill Cancer Centre at McGill University

Luis Souhami
Ph: 514-934-1934ext42953
Email: evelyn.ortega@muhc.mcgill.ca

Hong Kong

Chai Wan

Pamela Youde Nethersole Eastern Hospital

Inda Sung Soong
Ph: 888-823-5923
Email: ctsucontact@westat.com

Republic of Korea

Seoul

Korea Cancer Center Hospital

Sang Y Ryu
Ph: 011-82-02-9702-114

Seoul National University Hospital

Jae W Kim
Ph: 011-82-760-2384

Kyeonggi-do
Seongnam City

Seoul National University Bundang Hospital

Kidong Kim
Ph: 011-82-760-2384

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00980954
ClinicalTrials.gov processed this data on May 15, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.