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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
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

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:

Interventional

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

Authority:

United States: Federal Government

Study ID:

CDR0000065771

NCT ID:

NCT00003078

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
Women's Cancer CenterPalo Alto, California  94304
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
CCOP - Baptist Cancer InstituteMemphis, Tennessee  38117
Brookview Research, Inc.Nashville, Tennessee  37203
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - Columbia River ProgramPortland, Oregon  97213
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
CCOP - EvanstonEvanston, Illinois  60201
North Shore University HospitalManhasset, New York  11030
CCOP - Sooner StateTulsa, Oklahoma  74136
Medicine BranchBethesda, Maryland  20892
Radiation Oncology BranchBethesda, Maryland  20892
Fred J. Woods Radiation Therapy Center/St. Joseph's Cancer InstituteTampa, Florida  33607