AzTrials
AzTrials

Cervical CancerPhase 3NCT00054067

Chemotherapy and Radiation Therapy With or Without Surgery in Treating Patients With Stage I Cancer of the Cervix

A Phase 3 study testing cisplatin, adjuvant therapy and conventional surgery in people with Cervical Cancer, run by Gynecologic Oncology Group at 50 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer
What is being tested?
cisplatin, adjuvant therapy and conventional surgery
Type of treatment
Surgery or procedure
How many people
Not given
Where
50 sitesin 2 countries
Study dates
Feb 2003to Apr 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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)

Trial locations and contacts

50 sites in 2 countries.

50 sites in 2 countries

United States49 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont, 05401

  • Cooper University Hospital

    Camden, New Jersey, 08103-1489

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612-3824

  • MBCCOP - University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267-0526

  • Ireland Cancer Center

    Cleveland, Ohio, 44106

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Central Illinois

    Decatur, Illinois, 62794-9640

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • CCOP - Evanston

    Evanston, Illinois, 60201

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1002

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1740

  • Women's Cancer Center at Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6188

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-2516

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68106

  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, 92868

  • Abramson Cancer Center at University of Pennsylvania Medical Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3180

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11790-7775

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

Other trials in United States

Japan1 site

  • Kagoshima City Hospital

    Kagoshima, 892-8580

Other trials in Japan

About this study

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

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of radiation therapy combined with chemotherapy, with or without surgery, is more effective in treating early cancer of the cervix.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery followed by different regimens of radiation therapy and chemotherapy with that of chemotherapy and radiation therapy alone in treating patients who have stage I cancer of the cervix.

Read the detailed description

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.

Conditions
Cervical Cancer
Being tested
cisplatin, adjuvant therapy, conventional surgery, brachytherapy, radiation therapy
Keywords
cervical adenocarcinoma, cervical adenosquamous cell carcinoma, cervical squamous cell carcinoma, stage IB cervical cancer
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study startFeb 2003
  3. Primary completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054067
Sponsor's protocol ID
CDR0000269821
Other IDs
GOG-0201
Status last verified
Apr 2013
First submitted
5 Feb 2003
Last updated
11 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, adjuvant therapy and conventional surgery in people with Cervical Cancer, run by Gynecologic Oncology Group at 50 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in