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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00002546
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 11, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Information provided by:
GOG Foundation

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Sarcoma Drug: cisplatin Drug: ifosfamide Procedure: adjuvant therapy Radiation: radiation therapy Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Primary Purpose: Treatment
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
Study Start Date : December 1993
Actual Primary Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ifosfamide

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002546


Locations
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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Investigators
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Study Chair: Aaron H. Wolfson, MD University of Miami Sylvester Comprehensive Cancer Center
Study Chair: Higinia R. Cardenes, MD, PhD Indiana University Melvin and Bren Simon Cancer Center
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00002546    
Other Study ID Numbers: GOG-0150
CDR0000063303 ( Other Identifier: NIH )
ECOG-G150
NCI-2012-02226 ( Other Identifier: NCI )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Keywords provided by GOG Foundation:
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
uterine carcinosarcoma
Additional relevant MeSH terms:
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Sarcoma
Carcinosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
 Ifosfamide
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action