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Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation


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

Thank you

Trial Information

Treatment of Patients With Stage IB2 Carcinoma of the Cervix: A Randomized Comparison of Radical Hysterectomy and Tailored Chemo-Radiation Versus Primary Chemo-Radiation


OBJECTIVES:

- Compare progression-free survival and survival of patients with stage IB2 carcinoma of
the cervix after radical hysterectomy with tailored chemoradiotherapy vs primary
chemoradiotherapy.

- Compare the toxicity of these regimens in these patients.

- Compare the health-related quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: (Surgery followed by chemoradiotherapy): Patients undergo exploratory laparotomy
followed by radical hysterectomy and bilateral pelvic and para-aortic lymphadenectomy.
Depending on the findings at surgery, the radical hysterectomy and lymphadenectomy are
either completed or aborted.

- Aborted hysterectomy: Patients with aborted hysterectomy are assigned to 1 of 3
groups, depending on the findings at surgery.

- Group 1: Within 4 weeks of surgery, patients undergo pelvic radiotherapy 5
times weekly for 4-6 weeks and intracavitary irradiation during or after
external radiotherapy. Patients also receive concurrent cisplatin IV over 1
hour once weekly for a total of 5-6 doses.

- Group 2: Patients receive radiotherapy and cisplatin as in group 1 with
additional extended field radiotherapy.

- Group 3: Patients receive further treatment at the discretion of the
investigator.

- Completed hysterectomy: Patients completing the radical hysterectomy are assigned
to 1 of 3 groups, depending on the findings at surgery.

- Group A: Patients receive treatment as in group 1 above without intracavity
irradiation.

- Group B: Patients receive treatment as in group 2 above without intracavity
irradiation.

- Group C: Patients receive no further treatment.

- Arm II (Primary chemoradiotherapy): Patients undergo pelvic radiotherapy 5 times weekly
for 4-6 weeks and intracavity irradiation during or after external radiotherapy.
Patients also receive concurrent cisplatin IV over 1 hour once weekly for a total of 6
doses.

Quality of life is assessed at baseline, during week 5 of therapy, and then at 3, 6, and 12
months.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 740 patients (370 per treatment arm) will be accrued for this
study within 7.5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IB2 invasive carcinoma of the uterine cervix of one of
the following types:

- Squamous cell carcinoma

- Adenocarcinoma

- Adenosquamous carcinoma

- Primary, previously untreated disease

- Exophytic cervical lesions greater than 4 cm in diameter OR

- Cervical expansion to greater than 4 cm in diameter, presumed to be the result of
principal involvement with cancer

- No evidence of extrauterine disease other than pelvic lymph node involvement (by
clinical and radiographic examinations)

- No para-aortic lymph nodal disease (suspected on CT scan, MRI, positron-emission
tomography, or lymphangiogram) unless nodes are confirmed to be pathologically
negative (by CT-guided biopsy or extraperitoneal lymph node dissection)

- Eligible for radical hysterectomy and lymph node dissection

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal

- Alkaline phosphatase no greater than 3 times normal

Renal

- Creatinine no greater than 2.0 mg/dL

- No renal abnormalities requiring modification of radiation fields

Gastrointestinal

- No gastrointestinal bleeding

- No intestinal obstruction

Other

- Not pregnant

- Negative pregnancy test

- No septicemia or severe infection

- No other invasive malignancy with any evidence of disease within the past 5 years
except nonmelanoma skin cancer

- No circumstances that would preclude study completion or required follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

- No prior hysterectomy (total or subtotal)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

D. Scott McMeekin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000269821

NCT ID:

NCT00054067

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Cervical Cancer
  • cervical adenocarcinoma
  • cervical adenosquamous cell carcinoma
  • cervical squamous cell carcinoma
  • stage IB cervical cancer
  • Uterine Cervical Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
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 Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Abington Memorial HospitalAbington, Pennsylvania  19001
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
MBCCOP - University of Illinois at ChicagoChicago, Illinois  60612
CCOP - EvanstonEvanston, Illinois  60201
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Southeast Gynecologic Oncology AssociatesKnoxville, Tennessee  37917
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Cooper University HospitalCamden, New Jersey  08103
Fletcher Allen Health Care - Medical Center CampusBurlington, Vermont  05401
Abramson Cancer Center at University of Pennsylvania Medical CenterPhiladelphia, Pennsylvania  19104
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Women's Cancer Center at Community Hospital of Los GatosLos Gatos, California  95032