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A Randomized Comparison of Radiation vs Radiation Plus Weekly Cisplatin vs Radiation Plus PVI (Protracted Venous Infusion) 5-FU in Patients With Stage II-B, III-B, and IV-A Carcinoma of the Cervix With Negative Paraaortic Nodes

Phase 3
Not Enrolling
Cervical Cancer

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Trial Information

A Randomized Comparison of Radiation vs Radiation Plus Weekly Cisplatin vs Radiation Plus PVI (Protracted Venous Infusion) 5-FU in Patients With Stage II-B, III-B, and IV-A Carcinoma of the Cervix With Negative Paraaortic Nodes

OBJECTIVES: I. Compare the progression-free survival and survival of patients with advanced
cervical cancer limited to the pelvis receiving either radiotherapy alone, or radiotherapy
plus weekly cisplatin, or radiotherapy plus prolonged venous infusion (PVI) of fluorouracil.
[Radiotherapy alone regimen closed 8/18/98] II. Determine the relative toxic effects of
radiation therapy plus chemotherapy with either weekly cisplatin or PVI fluorouracil
compared to radiation alone. [Radiotherapy alone regimen closed 8/18/98] IV. Compare the
progression-free survival and survival of patients with advanced cervical cancer limited to
the pelvis and who smoke at the time of diagnosis versus non-smokers and those who smoke
during radiation therapy versus those who quit.

OUTLINE: This is a randomized study. Patients are stratified by stage, performance of
para-aortic lymphadenectomy, and brachytherapy method (HDR vs LDR). Prior to treatment
patients complete a questionnaire regarding past and present smoking history and exposure to
secondhand smoke. In arm I, patients undergo external radiation therapy to the pelvis once
daily 5 times a week for 5 weeks. Then, patients receive either low dose rate or high dose
rate intracavitary brachytherapy in one or two applications or 5 fractions once or twice a
week, respectively. If intracavitary radiation therapy cannot be performed, then shrinking
field technique is executed. In addition, patients receive parametrial boost once daily for
3 to 5 days during intracavitary brachytherapy. Concurrently, patients receive IV cisplatin
once a week for 5 weeks beginning on day 1 of external radiation therapy and once during the
parametrial boost. Patients in arm II receive external radiation therapy and brachytherapy
as previously described. [Arm II closed 8/18/98] In arm III, patients undergo external
radiation therapy as described in arm I. In addition, patients receive prolonged venous
infusion (PVI) fluorouracil daily for 5 days during external beam radiation therapy (whole
pelvis and parametrial boost). If all 6 courses of cisplatin or fluorouracil cannot be
administered during external radiation therapy, then the sixth course of chemotherapy will
be given during brachytherapy. Patients are followed every 3 months for the first 2 years,
then every 6 months for the next 3 years, then annually until death.

PROJECTED ACCRUAL: This study will accrue a maximum of 870 patients over 66 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Primary, previously untreated, histologically confirmed invasive
squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix
stage IIB, IIIB, or IVA Negative para-aortic lymph nodes determined by lymphangiogram, CT,
MRI, or lymphadenectomy (excluding suspicious para-aortic lymph nodes) Para-aortic
lymphadenectomy must be performed extraperitoneally or by laparoscopy No histologically
confirmed cancer involving the para-aortic lymph nodes, intraperitoneal disease, or
positive peritoneal cytology No recurrent invasive carcinoma of the uterine cervix,
regardless of previous treatment or cervix cancers other than squamous cell,
adenosquamous, or adenocarcinoma No carcinoma of the cervical stump

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-3 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 times normal SGOT and alkaline phosphatase no
greater than 3 times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No
septicemia or severe infection Not pregnant Negative pregnancy test Effective
contraception required of fertile patients No other invasive malignancy unless disease
free for at least 5 years and no prior cancer treatment that contraindicated this protocol
therapy No concomitant malignancy other than nonmelanomatous skin cancer Must complete
smoking history questionnaire and provide urine specimen for cotinine analysis

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy to
the pelvis Surgery: No prior hysterectomy

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Rachelle M. Lanciano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Delaware County Regional Cancer Center at Delaware County Memorial Hospital


United States: Federal Government

Study ID:




Start Date:

October 1997

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage III cervical cancer
  • stage IIB cervical cancer
  • stage IVA cervical cancer
  • cervical squamous cell carcinoma
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • Uterine Cervical Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Alabama Comprehensive Cancer Center Birmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Chao Family Comprehensive Cancer Center Orange, California  92868
University of Colorado Cancer Center Denver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown University Washington, District of Columbia  20007
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
MBCCOP - Hawaii Honolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
Albert B. Chandler Medical Center, University of Kentucky Lexington, Kentucky  40536-0084
Johns Hopkins Oncology Center Baltimore, Maryland  21287
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
CCOP - Ann Arbor Regional Ann Arbor, Michigan  48106
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Cooper Hospital/University Medical Center Camden, New Jersey  08103
Cancer Center of Albany Medical Center Albany, New York  12208
State University of New York Health Science Center at Brooklyn Brooklyn, New York  11203
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
University of Oklahoma College of Medicine Oklahoma City, Oklahoma  73190
Abington Memorial Hospital Abington, Pennsylvania  19001
Milton S. Hershey Medical Center Hershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia, Pennsylvania  19107
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Medical University of South Carolina Charleston, South Carolina  29425-0721
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Cancer Center, University of Virginia HSC Charlottesville, Virginia  22908
University of Washington Medical Center Seattle, Washington  98195-6043
Tacoma General Hospital Tacoma, Washington  98405
CCOP - Greater Phoenix Phoenix, Arizona  85006-2726
Women's Cancer Center Palo Alto, California  94304
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
Pennsylvania Hospital Philadelphia, Pennsylvania  19107
CCOP - Baptist Cancer Institute Memphis, Tennessee  38117
Brookview Research, Inc. Nashville, Tennessee  37203
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbia River Program Portland, Oregon  97213
Delaware County Memorial Hospital Drexel Hill, Pennsylvania  19026
CCOP - Evanston Evanston, Illinois  60201
North Shore University Hospital Manhasset, New York  11030
CCOP - Sooner State Tulsa, Oklahoma  74136
Medicine Branch Bethesda, Maryland  20892
Radiation Oncology Branch Bethesda, Maryland  20892
Fred J. Woods Radiation Therapy Center/St. Joseph's Cancer Institute Tampa, Florida  33607