Trial Title:
Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
NCT ID:
NCT00980954
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Paclitaxel
Carboplatin
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
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
carboplatin
Description:
Intravenously
Arm group label:
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Intervention type:
Drug
Intervention name:
cisplatin
Description:
Intravenously
Arm group label:
Arm I: Cisplatin/Radiation Therapy
Arm group label:
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
Intravenously
Arm group label:
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Intervention type:
Radiation
Intervention name:
intensity-modulated radiation therapy
Description:
Daily fractions
Arm group label:
Arm I: Cisplatin/Radiation Therapy
Arm group label:
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Other name:
IMRT
Intervention type:
Radiation
Intervention name:
standard external beam radiation therapy
Description:
Daily fractions
Arm group label:
Arm I: Cisplatin/Radiation Therapy
Arm group label:
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
Other name:
EBRT
Intervention type:
Radiation
Intervention name:
Optional brachytherapy boost
Description:
Low-dose rate (20-25 Gy single application) or high-dose rate (12-18 Gy 2-3
applications), dependent on external beam dose.
Arm group label:
Arm I: Cisplatin/Radiation Therapy
Arm group label:
Arm II: Cisplatin/Radiation Therapy + Carboplatin/Paclitaxel
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:
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 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama at Birmingham
Address:
City:
Birmingham
Zip:
35294
Country:
United States
Facility:
Name:
Providence Hospital
Address:
City:
Mobile
Zip:
36608
Country:
United States
Facility:
Name:
Providence Alaska Medical Center
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Facility:
Name:
Arizona Center for Cancer Care-Peoria
Address:
City:
Peoria
Zip:
85381
Country:
United States
Facility:
Name:
Saint Joseph's Hospital and Medical Center
Address:
City:
Phoenix
Zip:
85013
Country:
United States
Facility:
Name:
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Address:
City:
Burbank
Zip:
91505
Country:
United States
Facility:
Name:
Mercy San Juan Medical Center
Address:
City:
Carmichael
Zip:
95608
Country:
United States
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Facility:
Name:
Saint Joseph Hospital - Orange
Address:
City:
Orange
Zip:
92868
Country:
United States
Facility:
Name:
Pomona Valley Hospital Medical Center
Address:
City:
Pomona
Zip:
91767
Country:
United States
Facility:
Name:
Mercy Cancer Center
Address:
City:
Sacramento
Zip:
95816
Country:
United States
Facility:
Name:
Mercy General Hospital Radiation Oncology Center
Address:
City:
Sacramento
Zip:
95819
Country:
United States
Facility:
Name:
Saint Helena Hospital
Address:
City:
Saint Helena
Zip:
94574
Country:
United States
Facility:
Name:
University of California At San Diego
Address:
City:
San Diego
Zip:
92103
Country:
United States
Facility:
Name:
Penrose-Saint Francis Healthcare
Address:
City:
Colorado Springs
Zip:
80907
Country:
United States
Facility:
Name:
Hartford Hospital
Address:
City:
Hartford
Zip:
06102
Country:
United States
Facility:
Name:
The Hospital of Central Connecticut
Address:
City:
New Britain
Zip:
06050
Country:
United States
Facility:
Name:
University of Miami Sylvester Comprehensive Cancer Center at Deerfield Beach
Address:
City:
Deerfield Beach
Zip:
33442
Country:
United States
Facility:
Name:
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Facility:
Name:
Jackson Memorial Hospital-Holtz Children's Hospital
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
University of Miami Miller School of Medicine-Sylvester Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Facility:
Name:
Baptist Hospital of Miami
Address:
City:
Miami
Zip:
33176
Country:
United States
Facility:
Name:
Florida Hospital
Address:
City:
Orlando
Zip:
32803
Country:
United States
Facility:
Name:
Grady Health System
Address:
City:
Atlanta
Zip:
30303
Country:
United States
Facility:
Name:
Northside Hospital
Address:
City:
Atlanta
Zip:
30342
Country:
United States
Facility:
Name:
Northeast Georgia Medical Center
Address:
City:
Gainesville
Zip:
30501
Country:
United States
Facility:
Name:
Memorial Health University Medical Center
Address:
City:
Savannah
Zip:
31403
Country:
United States
Facility:
Name:
Saint Joseph's-Candler Health System
Address:
City:
Savannah
Zip:
31405
Country:
United States
Facility:
Name:
Queen's Medical Center
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Facility:
Name:
University of Hawaii
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Facility:
Name:
Saint Alphonsus Regional Medical Center
Address:
City:
Boise
Zip:
83706
Country:
United States
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Facility:
Name:
Rush University Medical Center
Address:
City:
Chicago
Zip:
60612
Country:
United States
Facility:
Name:
OSF Saint Francis Medical Center
Address:
City:
Peoria
Zip:
61637
Country:
United States
Facility:
Name:
Saint Vincent Anderson Regional Hospital/Cancer Center
Address:
City:
Anderson
Zip:
46016
Country:
United States
Facility:
Name:
Saint Francis Hospital and Health Centers
Address:
City:
Beech Grove
Zip:
46107
Country:
United States
Facility:
Name:
Franciscan Saint Margaret Health-Hammond Campus
Address:
City:
Hammond
Zip:
46320
Country:
United States
Facility:
Name:
Franciscan Saint Francis Health-Indianapolis
Address:
City:
Indianapolis
Zip:
46237
Country:
United States
Facility:
Name:
Michiana Hematology Oncology PC-Mishawaka
Address:
City:
Mishawaka
Zip:
46545-1470
Country:
United States
Facility:
Name:
University of Iowa Hospitals and Clinics
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Facility:
Name:
Mercy Medical Center - North Iowa
Address:
City:
Mason City
Zip:
50401
Country:
United States
Facility:
Name:
University of Kansas Medical Center
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Facility:
Name:
Kansas City Cancer Centers-Southwest
Address:
City:
Overland Park
Zip:
66210
Country:
United States
Facility:
Name:
Via Christi Regional Medical Center
Address:
City:
Wichita
Zip:
67214
Country:
United States
Facility:
Name:
University of Maryland/Greenebaum Cancer Center
Address:
City:
Baltimore
Zip:
21201
Country:
United States
Facility:
Name:
Greater Baltimore Medical Center
Address:
City:
Baltimore
Zip:
21204
Country:
United States
Facility:
Name:
Sinai Hospital of Baltimore
Address:
City:
Baltimore
Zip:
21215
Country:
United States
Facility:
Name:
Central Maryland Radiation Oncology in Howard County
Address:
City:
Columbia
Zip:
21044
Country:
United States
Facility:
Name:
Holy Cross Hospital
Address:
City:
Silver Spring
Zip:
20910
Country:
United States
Facility:
Name:
Hickman Cancer Center
Address:
City:
Adrian
Zip:
49221
Country:
United States
Facility:
Name:
Saint John Hospital and Medical Center
Address:
City:
Detroit
Zip:
48236
Country:
United States
Facility:
Name:
West Michigan Cancer Center
Address:
City:
Kalamazoo
Zip:
49007
Country:
United States
Facility:
Name:
Saint Joseph Mercy Port Huron
Address:
City:
Port Huron
Zip:
48060
Country:
United States
Facility:
Name:
Saint John Macomb-Oakland Hospital
Address:
City:
Warren
Zip:
48093
Country:
United States
Facility:
Name:
Abbott-Northwestern Hospital
Address:
City:
Minneapolis
Zip:
55407
Country:
United States
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Facility:
Name:
University of Mississippi Medical Center
Address:
City:
Jackson
Zip:
39216
Country:
United States
Facility:
Name:
Kansas City Cancer Center - South
Address:
City:
Kansas City
Zip:
64131
Country:
United States
Facility:
Name:
Kansas City Cancer Centers - North
Address:
City:
Kansas City
Zip:
64154
Country:
United States
Facility:
Name:
Kansas City Cancer Center-Lee's Summit
Address:
City:
Lee's Summit
Zip:
64064
Country:
United States
Facility:
Name:
Phelps County Regional Medical Center
Address:
City:
Rolla
Zip:
65401
Country:
United States
Facility:
Name:
Saint John's Mercy Medical Center
Address:
City:
Saint Louis
Zip:
63141
Country:
United States
Facility:
Name:
Mercy Hospital Springfield
Address:
City:
Springfield
Zip:
65804
Country:
United States
Facility:
Name:
CoxHealth South Hospital
Address:
City:
Springfield
Zip:
65807
Country:
United States
Facility:
Name:
Nebraska Methodist Hospital
Address:
City:
Omaha
Zip:
68114
Country:
United States
Facility:
Name:
The Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Facility:
Name:
Elliot Hospital
Address:
City:
Manchester
Zip:
03103
Country:
United States
Facility:
Name:
Cooper Hospital University Medical Center
Address:
City:
Camden
Zip:
08103
Country:
United States
Facility:
Name:
Morristown Memorial Hospital
Address:
City:
Morristown
Zip:
07962
Country:
United States
Facility:
Name:
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Address:
City:
Mount Holly
Zip:
08060
Country:
United States
Facility:
Name:
UMDNJ - New Jersey Medical School
Address:
City:
Newark
Zip:
07103
Country:
United States
Facility:
Name:
MD Anderson Cancer Center at Cooper-Voorhees
Address:
City:
Voorhees
Zip:
08043
Country:
United States
Facility:
Name:
Montefiore Medical Center-Weiler Division
Address:
City:
Bronx
Zip:
10461
Country:
United States
Facility:
Name:
Montefiore Medical Center
Address:
City:
Bronx
Zip:
10467-2490
Country:
United States
Facility:
Name:
State University of New York Downstate Medical Center
Address:
City:
Brooklyn
Zip:
11203
Country:
United States
Facility:
Name:
Memorial Sloan-Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Facility:
Name:
Highland Hospital
Address:
City:
Rochester
Zip:
14620
Country:
United States
Facility:
Name:
University of Rochester
Address:
City:
Rochester
Zip:
14642
Country:
United States
Facility:
Name:
Carolinas Medical Center
Address:
City:
Charlotte
Zip:
28203
Country:
United States
Facility:
Name:
Summa Akron City Hospital/Cooper Cancer Center
Address:
City:
Akron
Zip:
44304
Country:
United States
Facility:
Name:
Akron General Medical Center
Address:
City:
Akron
Zip:
44307
Country:
United States
Facility:
Name:
Summa Barberton Hospital
Address:
City:
Barberton
Zip:
44203
Country:
United States
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45267
Country:
United States
Facility:
Name:
Case Western Reserve University
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Facility:
Name:
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Facility:
Name:
Summa Health Center at Lake Medina
Address:
City:
Medina
Zip:
44256
Country:
United States
Facility:
Name:
UHHS-Chagrin Highlands Medical Center
Address:
City:
Orange Village
Zip:
44122
Country:
United States
Facility:
Name:
Southern Ohio Medical Center
Address:
City:
Portsmouth
Zip:
45662
Country:
United States
Facility:
Name:
Robinson Radiation Oncology
Address:
City:
Ravenna
Zip:
44266
Country:
United States
Facility:
Name:
Cancer Care Center, Incorporated
Address:
City:
Salem
Zip:
44460
Country:
United States
Facility:
Name:
Ireland Cancer Center at Firelands Regional Medical Center
Address:
City:
Sandusky
Zip:
44870
Country:
United States
Facility:
Name:
Flower Hospital
Address:
City:
Sylvania
Zip:
43560
Country:
United States
Facility:
Name:
University of Toledo
Address:
City:
Toledo
Zip:
43614
Country:
United States
Facility:
Name:
UHHS-Westlake Medical Center
Address:
City:
Westlake
Zip:
44145
Country:
United States
Facility:
Name:
Cancer Treatment Center
Address:
City:
Wooster
Zip:
44691
Country:
United States
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Facility:
Name:
Providence Portland Medical Center
Address:
City:
Portland
Zip:
97213
Country:
United States
Facility:
Name:
Providence Saint Vincent Medical Center
Address:
City:
Portland
Zip:
97225
Country:
United States
Facility:
Name:
Delaware County Memorial Hospital
Address:
City:
Drexel Hill
Zip:
19026
Country:
United States
Facility:
Name:
Reading Hospital
Address:
City:
West Reading
Zip:
19611
Country:
United States
Facility:
Name:
Lankenau Hospital
Address:
City:
Wynnewood
Zip:
19096
Country:
United States
Facility:
Name:
Women and Infants Hospital
Address:
City:
Providence
Zip:
02905
Country:
United States
Facility:
Name:
Rapid City Regional Hospital
Address:
City:
Rapid City
Zip:
57701
Country:
United States
Facility:
Name:
Sanford Cancer Center-Oncology Clinic
Address:
City:
Sioux Falls
Zip:
57104
Country:
United States
Facility:
Name:
University of Tennessee - Knoxville
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Methodist Hospital
Address:
City:
Houston
Zip:
77030
Country:
United States
Facility:
Name:
Intermountain Medical Center
Address:
City:
Murray
Zip:
84157
Country:
United States
Facility:
Name:
McKay-Dee Hospital Center
Address:
City:
Ogden
Zip:
84403
Country:
United States
Facility:
Name:
Dixie Medical Center Regional Cancer Center
Address:
City:
Saint George
Zip:
84770
Country:
United States
Facility:
Name:
Huntsman Cancer Institute/University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Facility:
Name:
Seattle Cancer Care Alliance
Address:
City:
Seattle
Zip:
98109
Country:
United States
Facility:
Name:
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Address:
City:
Yakima
Zip:
98902
Country:
United States
Facility:
Name:
Wheeling Hospital
Address:
City:
Wheeling
Zip:
26003
Country:
United States
Facility:
Name:
Saint Vincent Hospital
Address:
City:
Green Bay
Zip:
54301
Country:
United States
Facility:
Name:
Aurora Saint Luke's Medical Center
Address:
City:
Milwaukee
Zip:
53215
Country:
United States
Facility:
Name:
Froedtert and the Medical College of Wisconsin
Address:
City:
Milwaukee
Zip:
53226
Country:
United States
Facility:
Name:
Aurora West Allis Medical Center
Address:
City:
West Allis
Zip:
53227
Country:
United States
Facility:
Name:
McGill University Department of Oncology
Address:
City:
Montreal
Zip:
H2W 1S6
Country:
Canada
Facility:
Name:
Pamela Youde Nethersole Eastern Hospital
Address:
City:
Chai Wan
Country:
Hong Kong
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam City
Zip:
463-707
Country:
Korea, Republic of
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
110-744
Country:
Korea, Republic of
Facility:
Name:
Gangnam Severance Hospital
Address:
City:
Seoul
Zip:
135-720
Country:
Korea, Republic of
Facility:
Name:
Korea Cancer Center Hospital
Address:
City:
Seoul
Zip:
139-706
Country:
Korea, Republic of
Start date:
September 2009
Completion date:
August 31, 2028
Lead sponsor:
Agency:
Radiation Therapy Oncology Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
NRG Oncology
Agency class:
Other
Source:
Radiation Therapy Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00980954
