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

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00002546
First received: November 1, 1999
Last updated: July 8, 2013
Last verified: November 2005
  Purpose

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 Intervention Phase
Sarcoma
Drug: cisplatin
Drug: ifosfamide
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Estimated Enrollment: 216
Study Start Date: December 1993
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002546

  Show 65 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Eastern Cooperative Oncology Group
Investigators
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

Additional Information:
Publications:
Wolfson AH, Brady MF, Mannel RS, et al.: A Gynecologic Oncology Group randomized trial of whole abdominal irradiation (WAI) vs cisplatin-ifosfamide+mesna (CIM) in optimally debulked stage I-IV carcinosarcoma (CS) of the uterus. [Abstract] J Clin Oncol 24 (Suppl 18): A-5001, 256s, 2006.

ClinicalTrials.gov Identifier: NCT00002546     History of Changes
Other Study ID Numbers: CDR0000063303, GOG-0150, ECOG-G150
Study First Received: November 1, 1999
Last Updated: July 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
stage I uterine sarcoma
stage II uterine sarcoma
stage III uterine sarcoma
stage IV uterine sarcoma
uterine carcinosarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Cisplatin
Ifosfamide
Isophosphamide mustard
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014