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



Status:Recruiting
Conditions:Cervical Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:September 2009
End Date:August 2026

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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

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.

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.

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
We found this trial at
126
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1309 W 17th Street
Sioux Falls, South Dakota 57104
(605) 328-8000
Principal Investigator: Miroslaw A. Mazurczak
Phone: 605-328-1367
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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2500 Campus Rd
Honolulu, Hawaii 96822
(808) 956-8111
Univ of Hawaii Honolulu Community College is an integral part of the University of Hawai?i,...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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185 S Orange Ave
Newark, New Jersey 07103
(973) 972-4300
UMDNJ-New Jersey Medical School NJMS is committed to educating humanistic, culturally competent physicians who will...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
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808 North 39th Avenue
Yakima, Washington 98902
Principal Investigator: Sean F. Cleary
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Adrian, Michigan 49221
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Anchorage, Alaska 99508
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Atlanta, Georgia 30303
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
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2401 W Belvedere Ave
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155 5th St NE
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(330) 615-3000
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1600 Albany Street
Beech Grove, Indiana 46107
(317) 787–3311
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Carmichael, California 95608
Principal Investigator: Wiley Fowler, MD
Phone: 916-556-3301
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303 East Superior Street
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1653 W. Congress Parkway
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2600 Clifton Ave
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
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300 W 10th Ave
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
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22101 Moross Rd
Detroit, Michigan 48236
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Drexel Hill, Pennsylvania
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Duarte, California 91010
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743 Spring St NE
Gainesville, Georgia 30501
770-219-9000
Northeast Georgia Medical Center Northeast Georgia Health System (NGHS) is a not-for-profit community health system...
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
954-265-JDCH (5324)
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1301 Punchbowl St
Honolulu, Hawaii 96813
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Houston, Texas 77030
Principal Investigator: Ann H. Klopp
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Houston, Texas 77030
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Indianapolis, Indiana 46237
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200 Hawkins Dr,
Iowa City, Iowa 52242
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3901 Rainbow Blvd
Kansas City, Kansas 66160
(913) 588-5000
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Kansas City, Missouri 64131
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8700 N. Green Hills Road
Kansas City, Missouri 64154
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Kansas City Cancer Centers - North Through world-class research and patient care, The University of...
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Knoxville, Tennessee 37996
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8900 N Kendall Dr
Miami, Florida 33176
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9200 W Wisconsin Ave
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800 E 28th St
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5340 Holy Cross Pkwy
Mishawaka, Indiana 46545
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Mobile, Alabama 36685
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100 Madison Ave
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175 Madison Avenue
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940 NE 13th St
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1100 West Stewart Drive
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353 Fairmont Blvd
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