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TREATMENT OF PATIENTS WITH SUBOPTIMAL ('BULKY') STAGE IB CARCINOMA OF THE CERVIX: A RANDOMIZED COMPARISON OF RADICAL HYSTERECTOMY AND PELVIC AND PARA-AORTIC LYMPHADENECTOMY WITH OR WITHOUT NEOADJUVANT VINCRISTINE AND CISPLATIN CHEMOTHERAPY, PHASE III


Phase 3
N/A
N/A
Not Enrolling
Female
Cervical Cancer

Thank you

Trial Information

TREATMENT OF PATIENTS WITH SUBOPTIMAL ('BULKY') STAGE IB CARCINOMA OF THE CERVIX: A RANDOMIZED COMPARISON OF RADICAL HYSTERECTOMY AND PELVIC AND PARA-AORTIC LYMPHADENECTOMY WITH OR WITHOUT NEOADJUVANT VINCRISTINE AND CISPLATIN CHEMOTHERAPY, PHASE III


OBJECTIVES: I. Compare disease free survival, overall survival, and local control in
patients with bulky stage IB carcinoma of the cervix treated with radical hysterectomy and
pelvic and para-aortic lymphadenectomy with or without neoadjuvant vincristine and
cisplatin. II. Compare adverse effects of radical hysterectomy and pelvic and para-aortic
lymphadenectomy with or without neoadjuvant vincristine and cisplatin in these patients.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. Arm
I: Surgery. All patients undergo intra-abdominal and retroperitoneal exploratory laparotomy.
Patients without metastases also undergo radical hysterectomy with pelvic and para-aortic
lymphadenectomy. Beginning 2-4 weeks after surgery, patients with 1 or more positive lymph
nodes or positive surgical margins on the radical hysterectomy specimen receive adjunctive
radiotherapy 5 days each week for 4-6 weeks. Patients with histologically confirmed
metastases do not undergo radical hysterectomy with pelvic and para-aortic lymphadenectomy,
but receive radiotherapy 5 days each week for 6-8 weeks beginning 2-4 weeks after the
laparotomy. Patients who undergo radiotherapy also receive cisplatin IV over 1 hour on days
when radiotherapy is administered for up to 6 doses of cisplatin. Arm II: Patients receive
vincristine IV bolus immediately followed by cisplatin IV over 1 hour on days 1, 11, and 21.
Courses repeat every 21 days for up to 3 courses in the absence of disease progression or
unacceptable toxicity. Beginning approximately 4 weeks after the last doses of neoadjuvant
vincristine and cisplatin, patients receive surgery, radiotherapy, and cisplatin as in Arm
I. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 170-340 patients will be accrued for this study over
approximately 4.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Previously untreated, histologically proven invasive carcinoma of
the cervix Eligible histologies: Squamous Adenocarcinoma Adenosquamous Eligible stages:
Bulky stage IB, i.e.: Exophytic lesions 4 cm or greater in diameter OR Cervix expanded to
4 cm or greater and presumed clinically to result from cancer No extension beyond cervix
clinically and by IVP or CT with contrast

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Hematopoietic: WBC
at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than
1.5 times normal AST no greater than 3 times normal Alkaline phosphatase no greater than 3
times normal Renal: Creatinine no greater than 2.0 mg/dL Other: No septicemia or severe
infection No other concurrent malignancy within the past 5 years except curatively treated
nonmelanomatous skin cancer and prior malignancy therapy does not contraindicate current
protocol therapy Suitability for radical hysterectomy and lymphadenectomy required

PRIOR CONCURRENT THERAPY: No prior therapy for cervical cancer No prior pelvic irradiation

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gary L. Eddy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kaiser Permanente Medical Center - Bellflower

Authority:

United States: Federal Government

Study ID:

CDR0000078470

NCT ID:

NCT00002536

Start Date:

December 1996

Completion Date:

Related Keywords:

  • Cervical Cancer
  • stage IB cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Chao Family Comprehensive Cancer CenterOrange, California  92868
University of Colorado Cancer CenterDenver, Colorado  80262
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
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
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
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
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
Tacoma General HospitalTacoma, Washington  98405
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Southern California Permanante Medical GroupBellflower, California  90706
Community Hospital of Los GatosLos Gatos, California  95032
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Tufts University School of MedicineBoston, Massachusetts  02111
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Brookview Research, Inc.Nashville, Tennessee  37203
Fletcher Allen Health CareBurlington, Vermont  05401
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908