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Endometrial CancerPhase 3NCT00006027

Comparison of Radiation Therapy With or Without Combination Chemotherapy Following Surgery in Treating Patients With Stage I or Stage II Endometrial Cancer

A Phase 3 study testing cisplatin, paclitaxel and adjuvant therapy in people with Endometrial Cancer, run by Radiation Therapy Oncology Group at 29 sites in 2 countries.

Completed

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

Official record
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Trial summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
cisplatin, paclitaxel and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
Not given
Where
29 sitesin 2 countries
Study dates
Aug 2000to Jun 2004
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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed uterine confined endometrioid endometrial adenocarcinoma with one of the following:
  • Grade 2 or 3 carcinoma with more than 50% myometrial invasion (stage IC and IIA)
  • Grade 2 or 3 carcinoma with stromal invasion of the cervix (stage IIB)
  • No grade I adenocarcinoma
  • Less than 50% papillary serous or clear cell histology on pathologic specimen
  • Prior hysterectomy (total abdominal, vaginal hysterectomy, or laparoscopic-assisted vaginal hysterectomy) and bilateral salpingo-oophorectomy with or without additional surgical staging for endometrial cancer no more than 8 weeks prior to study
  • No known metastatic extrauterine metastases, known gross residual disease, positive peritoneal cytology, or distant metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,800/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 3 times normal

Renal:

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular:

  • No cardiac dysrhythmias

Other:

  • No other malignancy within the past 5 years except nonmelanomatous skin cancer
  • No medical contraindications to study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

United States28 sites

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Tufts - New England Medical Center

    Boston, Massachusetts, 02111

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Cooper University Hospital

    Camden, New Jersey, 08103-1489

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425-2233

  • Ellis Fischel Cancer Center at University of Missouri - Columbia

    Columbia, Missouri, 65203

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

    Denver, Colorado, 80010

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0587

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

    Hershey, Pennsylvania, 17033-0850

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1740

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Brookview Research, Inc.

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

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

    Orange, California, 92868

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11794-8091

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1065

Other trials in United States

Norway1 site

  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

About this study

Official title: A Phase III Study of Adjuvant Postoperative Irradiation With or Without Cisplatin/Taxol Chemotherapy Following TAH/BSO for Patients With Endometrial Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if radiation therapy is more effective with or without combination chemotherapy for endometrial cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without combination chemotherapy following surgery in treating patients who have stage I or stage II endometrial cancer.

Read the detailed description

OBJECTIVES:

  • Compare the relapse-free survival in patients with stage I or II endometrial cancer treated with adjuvant radiotherapy with or without cisplatin and paclitaxel after total abdominal hysterectomy and bilateral salpingo-oophorectomy.
  • Compare the patterns of recurrence and the acute and late toxicity profiles associated with these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (IC-IIA vs IIB). Patients are randomized to one of two treatment arms.

  • Arm I: Within 8 weeks after surgery, patients receive radiotherapy once daily 5 days a week for 5.5 weeks.
  • Arm II: Within 8 weeks after surgery, patients receive radiotherapy as in arm I concurrently with cisplatin IV over 2-4 hours on days 1 and 28. After completion of radiotherapy, patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 2-4 hours on days 56, 84, 112, and 140.

Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 436 patients (218 per treatment arm) will be accrued for this study.

Being tested
cisplatin, paclitaxel, adjuvant therapy, radiation therapy
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial adenoacanthoma, endometrial clear cell carcinoma, endometrial papillary serous carcinoma
Medical subject headings
Endometrial 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 posted27 Jan 2003 (estimated)
  2. Study startAug 2000
  3. Primary completionJun 2004

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
NCT00006027
Sponsor's protocol ID
RTOG-9905
Other IDs
CDR0000068040, GOG-0194
Status last verified
Aug 2013
First submitted
5 Jul 2000
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, paclitaxel and adjuvant therapy in people with Endometrial Cancer, run by Radiation Therapy Oncology Group at 29 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Norway. 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 NCT00006027.

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 22 Oct 2020.

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