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

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, Treatment18 and overRTOG 0724/GOG-0724
NCI-2011-01973, CDR0000654709, GOG-0724, RTOG-0724, NCT00980954

Trial Description

Summary

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. 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.

Further Study Information

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. To evaluate adverse events.

II. To evaluate overall survival.

III. To evaluate quality of life.

IV. To evaluate chemotherapy-induced neuropathy.

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

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

VII. To collect blood 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: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo standard external beam radiation therapy (EBRT) or intensity-modulated radiation therapy (IMRT) to the pelvis once daily 5 days a week for 5-6 weeks. Patients also receive concurrent cisplatin intravenously (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.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria

Inclusion Criteria:

No distant metastases, based upon the following minimum diagnostic workup (NOTE: patients with positive para-aortic nodes- completely resected, PET/CT negative are eligible):

History/physical examination within 56 days prior to study entry

Contrast-enhanced imaging of the abdomen and pelvis by either CT, magnetic resonance imaging (MRI), or whole body PET-CT (with or without contrast) within 90 days prior to registration (NOTE: whole body PET-CT is preferred)

Chest x-ray (posterioranterior [PA] and lateral) or chest CT within 70 days prior to study entry (except for those who have had whole body PET-CT)

Patients must have undergone radical hysterectomy (open, laparoscopically or robotic) and staging including pelvic node sampling or dissection for cervical carcinoma within 70 days prior to study entry (NOTE: if the patient did not have a para-aortic lymph node sampling/dissection, but had common iliac node dissection that was negative, a positron emission tomography [PET]-computed tomography [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)

Patient must provide study-specific informed consent prior to study entry

Patients with known human immunodeficiency virus (HIV) positive must have a cluster of differentiation (CD)4 cell count be >= 350 cells/mm^3 within 14 days prior to study entry (note, however, that HIV testing is not required for entry into this protocol)

Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) and/or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) within upper limits of institutional normal within 14 days prior to study entry

Alkaline phosphatase within upper limits of institutional normal within 14 days prior to study entry

Bilirubin =< 1.5 times normal 14 days prior to study entry

Serum creatinine =< 1.5 mg/dL within 14 days prior to study entry

White blood cell count >= 4000 cells/mm^3

Hemoglobin >= 10.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable)

Platelets >= 100,000 cells/mm^3

Absolute neutrophil count (ANC) >= 1,800 cells/mm^3

Zubrod performance status 0-1

Patients with clinical stage IA2, IB or IIA squamous, adenosquamous, or adenocarcinoma of the cervix who have any/all of the following high-risk features after surgery:

Positive pelvic nodes

Positive parametrium

Positive para-aortic nodes- completely resected, PET/CT negative (PET only required if positive para-aortic nodes during surgery)

Exclusion Criteria:

Patients who have gross residual disease or distant metastatic disease

Prior allergic reaction to carboplatin, paclitaxel, and/or cisplatin

Severe, active co-morbidity, defined as follows:

Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months

Transmural myocardial infarction within the last 6 months

Acute bacterial or fungal infection requiring intravenous 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; note, however, that coagulation parameters are not required for entry into this protocol

Prior radiation therapy to the pelvis that would result in overlap of radiation therapy fields

Prior systemic chemotherapy for the current cervical cancer; note that prior chemotherapy for a different cancer is allowable

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)

Patients can not have any neuroendocrine histology in pathology

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

NRG Oncology

  • National Cancer Institute
Anuja Jhingran, Principal Investigator

Trial Sites

U.S.A.

Alaska
Anchorage

Providence Alaska Medical Center

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

Matthew C. Solhjem
Principal Investigator

Arizona
Peoria

Arizona Center for Cancer Care-Peoria

Christopher Alan Biggs
Ph: 623-773-2873

Christopher Alan Biggs
Principal Investigator

Phoenix

Saint Joseph's Hospital and Medical Center

John Hall Farley
Ph: 301-319-2100

John Hall Farley
Principal Investigator

California
Burbank

Providence Saint Joseph Medical Center/Disney Family Cancer Center

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

Matthew C. Solhjem
Principal Investigator

La Jolla

UC San Diego Moores Cancer Center

Anuja Jhingran

Anuja Jhingran
Principal Investigator

Orange

Saint Joseph Hospital - Orange

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

Krishnansu Sujata Tewari
Principal Investigator

UC Irvine Health/Chao Family Comprehensive Cancer Center

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

Krishnansu Sujata Tewari
Principal Investigator

Pomona

Pomona Valley Hospital Medical Center

Yallapragada S. (Ram) Rao
Ph: 909-865-9555

Yallapragada S. (Ram) Rao
Principal Investigator

Sacramento

Sutter General Hospital

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

Christopher Uwe Jones
Principal Investigator

Saint Helena

Saint Helena Hospital

David John Tate
Ph: 707-967-3698

David John Tate
Principal Investigator

Colorado
Colorado Springs

Penrose-Saint Francis Healthcare

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

Loveland

McKee Medical Center

Keren Sturtz
Ph: 888-785-6789

Keren Sturtz
Principal Investigator

District of Columbia
Washington

Sibley Memorial Hospital

Mildred R. Chernofsky
Ph: 202-243-2373

Mildred R. Chernofsky
Principal Investigator

Florida
Kissimmee

Florida Hospital Kissimmee

Lee M. Zehngebot
Ph: 407-303-5623

Lee M. Zehngebot
Principal Investigator

Orlando

Florida Hospital Orlando

Lee M. Zehngebot
Ph: 407-303-5623

Lee M. Zehngebot
Principal Investigator

Georgia
Gainesville

Northeast Georgia Medical Center

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

Frank Greer Lake
Principal Investigator

Savannah

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

John A. Pablo
Ph: 800-622-6877

John A. Pablo
Principal Investigator

Memorial University Medical Center

James Joseph Burke
Ph: 912-350-8568

James Joseph Burke
Principal Investigator

Idaho
Boise

Saint Alphonsus Cancer Care Center-Boise

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Illinois
Chicago

Northwestern University

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

Eric D. Donnelly
Principal Investigator

Decatur

Decatur Memorial Hospital

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

James Lloyd Wade
Principal Investigator

Peoria

Methodist Medical Center of Illinois

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

James Lloyd Wade
Principal Investigator

OSF Saint Francis Medical Center

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

James Lloyd Wade
Principal Investigator

Indiana
Beech Grove

Franciscan St. Francis Health-Beech Grove

David Harry Moore
Ph: 317-851-2555

David Harry Moore
Principal Investigator

Fort Wayne

Parkview Hospital Randallia

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

Brian K. Chang
Principal Investigator

Radiation Oncology Associates PC

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

Brian K. Chang
Principal Investigator

Mishawaka

Michiana Hematology Oncology PC-Mishawaka

Binh Nguyen Tran
Ph: 574-237-1328

Binh Nguyen Tran
Principal Investigator

South Bend

Northern Indiana Cancer Research Consortium CCOP

Anuja Jhingran

Anuja Jhingran
Principal Investigator

Kansas
Kansas City

University of Kansas Cancer Center

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Overland Park

Kansas City Cancer Centers-Southwest

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Maryland
Baltimore

Greater Baltimore Medical Center

Paul Celano
Ph: 443-849-3706

Paul Celano
Principal Investigator

Sinai Hospital of Baltimore

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

Jeanette A.F. Linder
Principal Investigator

Silver Spring

Holy Cross Hospital

Sheela Darsani Modin
Ph: 310-754-7552

Sheela Darsani Modin
Principal Investigator

Michigan
Detroit

Saint John Hospital and Medical Center

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Kalamazoo

West Michigan Cancer Center

Raymond Sterling Lord
Ph: 269-373-7458

Raymond Sterling Lord
Principal Investigator

Port Huron

Saint Joseph Mercy Port Huron

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Warren

Saint John Macomb-Oakland Hospital

Samir Narayan
Ph: 734-712-4673

Samir Narayan
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center

James Tate Thigpen
Ph: 601-815-6700

James Tate Thigpen
Principal Investigator

Missouri
Kansas City

Kansas City Cancer Center - South

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Kansas City Cancer Centers - North

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Lee's Summit

Kansas City Cancer Center-Lee's Summit

Parvesh Kumar
Ph: 913-945-7552
Email: ctnursenav@kumc.edu

Parvesh Kumar
Principal Investigator

Rolla

Phelps County Regional Medical Center

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Saint Louis

Mercy Hospital Saint Louis

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Springfield

Mercy Hospital Springfield

Jay W. Carlson
Ph: 800-821-7532

Jay W. Carlson
Principal Investigator

Nebraska
Omaha

Nebraska Methodist Hospital

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

Tien-Shew William Huang
Principal Investigator

New Hampshire
Manchester

Elliot Hospital

Brian Robert Knab
Ph: 603-663-1800

Brian Robert Knab
Principal Investigator

New Jersey
Camden

Cooper Hospital University Medical Center

Tamara Anne LaCouture
Ph: 856-325-6757

Tamara Anne LaCouture
Principal Investigator

Morristown

Morristown Medical Center

Yana Pavel Goldberg
Ph: 973-971-5900

Yana Pavel Goldberg
Principal Investigator

Mount Holly

Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County

Lemuel S. Ariaratnam
Ph: 888-847-8823

Lemuel S. Ariaratnam
Principal Investigator

Voorhees

MD Anderson Cancer Center at Cooper-Voorhees

Tamara Anne LaCouture
Ph: 856-325-6757

Tamara Anne LaCouture
Principal Investigator

New Mexico
Albuquerque

University of New Mexico

Teresa L. Rutledge
Ph: 505-272-6972

Teresa L. Rutledge
Principal Investigator

New York
New York

Memorial Sloan-Kettering Cancer Center

Mario Mendes Leitao
Ph: 212-639-7202

Mario Mendes Leitao
Principal Investigator

Rochester

Highland Hospital

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

University of Rochester

Yuhchyau Chen
Ph: 585-275-5830

Yuhchyau Chen
Principal Investigator

North Carolina
Charlotte

Carolinas Medical Center/Levine Cancer Institute

Robert Victor Higgins
Ph: 704-355-2884

Robert Victor Higgins
Principal Investigator

Winston-Salem

Wake Forest University Health Sciences

Samuel Smith Lentz
Ph: 336-713-6771

Samuel Smith Lentz
Principal Investigator

Ohio
Akron

Akron General Medical Center

Mitchel L. Fromm
Ph: 330-344-6348

Mitchel L. Fromm
Principal Investigator

Summa Akron City Hospital/Cooper Cancer Center

Desiree E. Doncals
Ph: 330-375-6101

Desiree E. Doncals
Principal Investigator

Barberton

Summa Barberton Hospital

Desiree E. Doncals
Ph: 330-375-6101

Desiree E. Doncals
Principal Investigator

Columbus

Ohio State University Comprehensive Cancer Center

Anuja Jhingran

Anuja Jhingran
Principal Investigator

Portsmouth

Southern Ohio Medical Center

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

John Philip Kuebler
Principal Investigator

Ravenna

Robinson Radiation Oncology

Mitchel L. Fromm
Ph: 330-344-6348

Mitchel L. Fromm
Principal Investigator

Oklahoma
Oklahoma City

University of Oklahoma Health Sciences Center

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

Terence S. Herman
Principal Investigator

Oregon
Portland

Providence Portland Medical Center

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

Matthew C. Solhjem
Principal Investigator

Providence Saint Vincent Medical Center

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

Matthew C. Solhjem
Principal Investigator

Pennsylvania
Danville

Geisinger Medical Center

Thomas James Gergel
Ph: 570-271-5251

Thomas James Gergel
Principal Investigator

Philadelphia

Fox Chase Cancer Center

Stephanie Angela King
Ph: 215-728-4790

Stephanie Angela King
Principal Investigator

West Reading

Reading Hospital

Michael L. Haas
Ph: 610-988-9323

Michael L. Haas
Principal Investigator

Rhode Island
Providence

Women and Infants Hospital

Paul A. DiSilvestro
Ph: 401-274-1122

Paul A. DiSilvestro
Principal Investigator

South Carolina
Greenville

Greenville Health System Cancer Institute-Eastside

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greenville Health System Cancer Institute-Faris

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

Greer

Greenville Health System Cancer Institute-Greer

David Lawrence Grisell
Ph: 864-241-6251

David Lawrence Grisell
Principal Investigator

South Dakota
Rapid City

Rapid City Regional Hospital

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

Michael J. Swartz
Principal Investigator

Sioux Falls

Avera Cancer Institute

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

Luis A. Rojas-Espaillat
Principal Investigator

Tennessee
Knoxville

University of Tennessee - Knoxville

Larry Clinton Kilgore
Ph: 865-544-9773

Larry Clinton Kilgore
Principal Investigator

Texas
Houston

M D Anderson Cancer Center

Ann H. Klopp
Ph: 713-792-3245

Ann H. Klopp
Principal Investigator

Ann H. Klopp
Email: aklopp@mdanderson.org

Ann H. Klopp
Principal Investigator

The Methodist Hospital System

Aparna A. Kamat
Ph: 713-790-2700

Aparna A. Kamat
Principal Investigator

Utah
Logan

Logan Regional Hospital

Anuja Jhingran

Anuja Jhingran
Principal Investigator

Murray

Intermountain Medical Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Ogden

McKay-Dee Hospital Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Saint George

Dixie Medical Center Regional Cancer Center

R. Jeffrey Lee
Ph: 801-507-3950

R. Jeffrey Lee
Principal Investigator

Salt Lake City

Huntsman Cancer Institute/University of Utah

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

David K. Gaffney
Principal Investigator

Washington
Seattle

Seattle Cancer Care Alliance

Heidi Joy Gray
Ph: 206-616-8289

Heidi Joy Gray
Principal Investigator

West Virginia
Wheeling

Wheeling Hospital/Schiffler Cancer Center

Jondavid Pollock
Ph: 304-243-6442

Jondavid Pollock
Principal Investigator

Wisconsin
Green Bay

Saint Vincent Hospital

James L. Leenstra
Ph: 920-433-8889

James L. Leenstra
Principal Investigator

La Crosse

Gundersen Lutheran Medical Center

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

Collin D. Driscoll
Principal Investigator

Milwaukee

Aurora Saint Luke's Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Froedtert and the Medical College of Wisconsin

Beth A. Erickson
Ph: 414-805-4380

Beth A. Erickson
Principal Investigator

West Allis

Aurora West Allis Medical Center

Ali Mahdavi
Ph: 414-649-5717

Ali Mahdavi
Principal Investigator

Canada

Quebec
Montreal

McGill University Department of Oncology

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

Luis Souhami
Principal Investigator

Hong Kong

Chai Wan

Pamela Youde Nethersole Eastern Hospital

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

Inda Sung Soong
Principal Investigator

Republic of Korea

Seongnam City

Seoul National University Bundang Hospital

Kidong Kim
Ph: 011-82-760-2384

Kidong Kim
Principal Investigator

Seoul

Gangnam Severance Hospital

Jae-Hoon Kim
Email: clinical.trial@bms.com

Jae-Hoon Kim
Principal Investigator

Korea Cancer Center Hospital

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

Sang Young Ryu
Principal Investigator

Seoul National University Hospital

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

Jae Weon Kim
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00980954

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.