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SarcomaPhase 3NCT00002546

Radiation Therapy Compared With Combination Chemotherapy in Treating Patients With Cancer of the Uterus

A Phase 3 study testing cisplatin, ifosfamide and adjuvant therapy in people with Sarcoma, run by Gynecologic Oncology Group at 65 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 21 to 120 years, women only
Conditions the study is for
Sarcoma
What is being tested?
cisplatin, ifosfamide and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
216 participants
Where
65 sitesin 2 countries
Study dates
Dec 1993to Sep 2007
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 21 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary homologous or heterologous carcinosarcoma of the uterus (corpus and cervix)
  • Surgical stage I-IV disease, including positive adnexa, tumor invading the serosa, positive pelvic and/or para-aortic nodes, involvement of the mucosa of the bowel, bladder, or rectum, intra-abdominal metastases, positive pelvic washings, or vaginal involvement within planned radiation port
  • Prior total abdominal hysterectomy with bilateral salpingo-oophorectomy and maximum tumor resection of all gross intra-abdominal/pelvic disease, including grossly involved pelvic and para-aortic nodes within 8 weeks before study
  • No greater than 1 cm residual disease
  • Cervical sarcomas also allowed
  • No metastasis beyond the abdominal cavity at diagnosis, including the following:
  • Parenchymal liver metastasis
  • Lung metastasis
  • Positive inguinal lymph nodes
  • Positive scalene nodes
  • Radiographic or pathologic evidence of bone or brain metastasis

PATIENT CHARACTERISTICS:

Age:

  • 21 and over

Performance status:

  • GOG 0-2

Hematopoietic:

  • WBC at least 3,000/mm3
  • Granulocyte count at least 1,500/mm3
  • Platelet count at least 100,000/mm3

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal
  • Albumin at least 3 g/dL
  • No acute hepatitis

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Other:

  • No septicemia
  • No severe infection
  • No severe gastrointestinal bleeding
  • No prior invasive or concurrent malignancy within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior hormonal therapy allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No prior therapy that would preclude study therapy

Trial locations and contacts

65 sites in 2 countries.

65 sites in 2 countries

United States64 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001-3788

  • MBCCOP - University of New Mexico HSC

    Albuquerque, New Mexico, 87131

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Cancer Center at Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus

    Burlington, Vermont, 05401

  • Cancer Institute of New Jersey at the Cooper University Hospital

    Camden, New Jersey, 08103-1489

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

    Chapel Hill, North Carolina, 27599-7570

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Rush University 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

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44106

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • CCOP - Geisinger Clinic and Medical Center

    Danville, Pennsylvania, 17822-2001

  • CCOP - Central Illinois

    Decatur, Illinois, 62794-9640

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80010

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • 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

  • Gynecologic Oncology Network

    Greenville, North Carolina, 27858

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

    Hershey, Pennsylvania, 17033-0850

  • Study site

    Hinsdale, Illinois, 60521

  • 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

  • Keesler Medical Center - Keesler Air Force Base

    Keesler Air Force Base, Mississippi, 39534-2576

  • Southeast Gynecologic Oncology Associates

    Knoxville, Tennessee, 37917

  • CCOP - Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Women's Cancer Center - Los Gatos

    Los Gatos, California, 95032

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

    Nashville, Tennessee, 37232-2516

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73104

  • 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 the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • CCOP - Western Regional, Arizona

    Phoenix, Arizona, 85006-2726

  • UPMC Cancer Center at Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213-3180

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Saint Joseph Regional Medical Center

    South Bend, Indiana, 46617

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65807

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11790-7775

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • 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

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

  • UMASS Memorial Cancer Center - University Campus

    Worcester, Massachusetts, 01605-2982

Other trials in United States

South Africa1 site

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

About this study

Official title: A Phase III Randomized Study of Accelerated Hyperfractionated Whole Abdominal Radiotherapy (AHWAR) Versus Combination Ifosfamide-Mesna With Cisplatin in Optimally Debulked Stage I, II, III, or IV Carcinosarcoma (CS) of The Uterus

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 whether radiation therapy is more effective than combination chemotherapy in treating patients with cancer of the uterus.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to combination chemotherapy in treating patients with cancer of the uterus.

Read the detailed description

OBJECTIVES:

  • Compare the survival, progression-free interval, and failure patterns in patients with optimally debulked stage I-IV carcinosarcoma of the uterus treated with whole abdominal radiotherapy vs ifosfamide and cisplatin.
  • Compare the incidence and type of acute and late adverse events observed with these treatment regimens in this patient population.

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

  • Arm I: Patients receive whole abdominal radiotherapy 5 days a week for 4 weeks, followed by radiotherapy boost to the pelvis 5 days a week for 2.2 weeks.
  • Arm II: Patients receive cisplatin IV followed by ifosfamide IV over 1 hour on days 1-4. Treatment continues every 3 weeks for 3 courses.

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

PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 6 years.

Conditions
Sarcoma
Being tested
cisplatin, ifosfamide, adjuvant therapy, radiation therapy
Keywords
stage I uterine sarcoma, stage II uterine sarcoma, stage III uterine sarcoma, stage IV uterine sarcoma, uterine carcinosarcoma
Medical subject headings
Sarcoma

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 posted27 Jan 2003 (estimated)
  2. Study startDec 1993
  3. Primary completionSep 2007

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
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002546
Sponsor's protocol ID
GOG-0150
Other IDs
CDR0000063303, ECOG-G150, NCI-2012-02226
Status last verified
Feb 2016
First submitted
1 Nov 1999
Last updated
11 Feb 2016
Results posted
No

Publications

  • Wolfson AH, Brady MF, Rocereto T, Mannel RS, Lee YC, Futoran RJ, Cohn DE, Ioffe OB. A gynecologic oncology group randomized phase III trial of whole abdominal irradiation (WAI) vs. cisplatin-ifosfamide and mesna (CIM) as post-surgical therapy in stage I-IV carcinosarcoma (CS) of the uterus. Gynecol Oncol. 2007 Nov;107(2):177-85. doi: 10.1016/j.ygyno.2007.07.070. Epub 2007 Sep 5.

    PubMed 17822748

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, ifosfamide and adjuvant therapy in people with Sarcoma, run by Gynecologic Oncology Group at 65 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: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, South Africa. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT00002546, which also lists 1 linked publication.

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 Feb 2016.

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