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Clinical Trials (PDQ®)

Clinical Trials (PDQ®)

Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive care, TreatmentActive18 and overNCI, OtherCDR0000629591
GOG-0249, NCT00807768

Trial Description

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether pelvic radiation therapy is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

PURPOSE: This randomized phase III trial is studying pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer.

Further Study Information

OBJECTIVES:

Primary

  • To compare the recurrence-free survival of patients with high-risk stage I or II endometrial carcinoma treated with pelvic radiotherapy vs vaginal cuff brachytherapy, paclitaxel, and carboplatin.

Secondary

  • To compare survival of patients treated with these regimens.
  • To compare patterns of failure in patients treated with these regimens.
  • To compare physical functioning, fatigue, and neurotoxicity in patients treated with these regimens.
  • To correlate primary comorbid illnesses and obesity with survival, fatigue, and physical functioning.
  • To evaluate the psychometric properties (e.g., construct validity, reliability, sensitivity to treatment, and responsiveness over time) of the PROMIS Fatigue-SF1.
  • To evaluate fatigue measurement equivalence between patients with endometrial cancer and age-matched women from the general population of the United States.

OUTLINE: This is a multicenter study. Patients are stratified according to extent of surgery (hysterectomy and bilateral salpingo-oophorectomy without lymph node sampling, lymph node dissection, or lymphadenectomy vs hysterectomy and bilateral salpingo-oophorectomy with lymph node sampling, lymph node dissection, or lymphadenectomy). Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology who are randomized to arm I are also stratified according to intent to use vaginal cuff brachytherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conventional or intensity-modulated pelvic radiotherapy once daily, 5 days a week, for 5-6 weeks (total of 25-28 fractions) in the absence of disease progression or unacceptable toxicity. Patients with stage II disease or stage I disease with a confirmed diagnosis of clear cell and/or papillary serous histology may also undergo 1 or 2 intravaginal (i.e., vaginal cuff) brachytherapy boost treatments.
  • Arm II: Patients undergo vaginal cuff brachytherapy comprising 3-5 high-dose rate brachytherapy treatments over approximately 2 weeks or 1 or 2 low-dose rate brachytherapy treatments over 1-2 days. Beginning within 3 weeks after initiating brachytherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Chemotherapy repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients complete questionnaires to assess quality of life, neurotoxicity, and fatigue at baseline, 4 weeks, 10-11 weeks, 8 months, and 14 months.

After completion of study therapy, patients are followed periodically for up to 10 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of endometrial carcinoma, meeting 1 of the following criteria:
  • Stage I disease with high-intermediate risk factors with positive or negative cytology (e.g., grade 2 or 3 tumor, presence of lymphovascular space invasion, and/or outer half myometrial invasion), meeting 1 of the following criteria:
  • Age ≥ 70 years with 1 risk factor
  • Age ≥ 50 years with 2 risk factors
  • Age ≥ 18 years with 3 risk factors
  • Stage II (occult or gross involvement) disease (any histology) with or without risk factors
  • Occult disease is defined as lesions that are identified as an incidental finding after hysterectomy in the absence of gross cervical disease
  • Stage I-II disease with serous or clear cell histology with or without other risk factors allowed provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement), and with peritoneal cytology negative for malignancy
  • Has undergone hysterectomy and bilateral salpingo-oophorectomy (laparotomy or laparoscopic approach, including robot-assisted) with or without pelvic and para-aortic lymphadenectomy within the past 4-12 weeks
  • If nodal dissection was not performed, pelvic and para-aortic nodes must be clinically negative with no evidence of distant disease by post-operative, pre-treatment CT scan/MRI
  • Suspicious nodes that have been biopsied (re-staging surgery, fine-needle aspiration) allowed provided they are pathologically negative
  • No pathologically confirmed spread of disease to pelvic or para-aortic lymph nodes or adnexal structures, and/or other anatomic sites, or serous or clear cell histology and positive cytologic washings
  • No recurrent disease
  • No surgical or clinical stage III or IV endometrial carcinoma
  • No sarcoma, carcinosarcoma (i.e., malignant mixed mullerian tumor), or non-epithelial uterine malignancies (i.e., leiomyosarcoma of the uterine corpus)

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • ANC ≥ 1,500/mcl
  • Platelet count ≥ 100,000/mcl
  • Serum creatinine normal OR creatinine clearance > 50 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 2.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • No neuropathy (sensory or motor) > grade 1
  • No other invasive malignancy within the past 5 years except non-melanoma skin cancer
  • No contraindications to pelvic radiotherapy (e.g., pelvic kidney, connective tissue disease, or inflammatory bowel disease)

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior non-surgical therapy for endometrial cancer, including chemotherapy, radiotherapy (e.g., pre-operative or post-operative brachytherapy), hormonal therapy, or biological therapy
  • No prior systemic chemotherapy or radiotherapy for another malignancy
  • No concurrent whole-abdominal, extended-field, or interstitial radiotherapy
  • No concurrent erythropoietin therapy
  • Concurrent enrollment on GOG-0210 (molecular marker study) allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

Gynecologic Oncology Group

National Cancer Institute

D. Scott McMeekinStudy Chair

Marcus E. Randall

Trial Sites

U.S.A.
California
  Los Angeles
 Kaiser Permanente Medical Center - Los Angeles
 Scott E. Lentz Ph: 626-564-3455
  Santa Clara
 Kaiser Permanente Medical Center - Santa Clara Homestead Campus
 Louis Fehrenbacher Ph: 626-564-3455
Illinois
  Mount Vernon
 Good Samaritan Regional Health Center
 Bethany G. Sleckman Ph: 913-948-5588
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
Massachusetts
  Boston
 Tufts Medical Center Cancer Center
 Michael G Kelly Ph: 336-713-6771
  Email: ContactUsCancerCenter@TuftsMedicalCenter.org
Michigan
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Sheldon Allen Weiner Ph: 248-551-7695
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
Missouri
  Cape Girardeau
 Saint Francis Medical Center
 Bethany G. Sleckman Ph: 913-948-5588
  Saint Louis
 CCOP - St. Louis-Cape Girardeau
 Bethany G. Sleckman Ph: 913-948-5588
 David C. Pratt Cancer Center at St. John's Mercy
 Bethany G. Sleckman Ph: 913-948-5588
New Jersey
  Morristown
 Carol G. Simon Cancer Center at Morristown Memorial Hospital
 Brian M Slomovitz Ph: 973-971-5900
  Summit
 Overlook Hospital
 Brian M Slomovitz Ph: 973-971-5900
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Carol Aghajanian Ph: 212-639-7202
  Rochester
 Daisy Marquis Jones Radiation Oncology Center at Highland Hospital of Rochester
 Yuhchyau Chen Ph: 585-275-5830
 James P. Wilmot Cancer Center at University of Rochester Medical Center
 Yuhchyau Chen Ph: 585-275-5830
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
South Carolina
  Anderson
 AnMed Cancer Center
 David Griffin Ph: 864-241-6251
Washington
  Yakima
 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
 Sean F. Cleary Ph: 877-902-3324
West Virginia
  Wheeling
 Schiffler Cancer Center at Wheeling Hospital
 Jon David Pollock Ph: 304-243-6442
Wisconsin
  Grafton
 Aurora Cancer Care-Grafton
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Green Bay
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Mequon
 Columbia Saint Mary's Hospital - Ozaukee
 Carl E. Olson Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
  Milwaukee
 Aurora Sinai Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
 Columbia-Saint Mary's Cancer Care Center
 Carl E. Olson Ph: 414-326-2675
  Email: clinicaltrials@columbia-stmarys.org
  Racine
 All Saints Cancer Center at Wheaton Franciscan Healthcare
 James H. Taylor Ph: 414-874-4541
  Email: Kelli.holton@wfhc.org
  Summit
 Aurora Medical Center
 Ali Mahdavi Ph: 414-649-5717
  Email: ucstudy@uci.edu
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Andrew W Yetter Ph: 800-252-2990

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00807768
ClinicalTrials.gov processed this data on September 25, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.