Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 and over	NCI	GOG-0249 GOG-0249, NCT00807768

Objectives

Primary

1. 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

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

Entry Criteria

Disease Characteristics:

• Diagnosis of endometrial carcinoma, meeting 1 of the following criteria:
  • Stage I-IIA disease with high-intermediate risk factors (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 IIB (occult) 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-IIB (occult) disease with serous or clear cell histology with or without other risk factors



• Has undergone hysterectomy and bilateral salpingo-oophorectomy (open or laparoscopic approach) 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, gross disease to the cervix, or 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)

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

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 nonmelanoma skin cancer
• No contraindications to pelvic radiotherapy (e.g., pelvic kidney, connective tissue disease, or inflammatory bowel disease)

Expected Enrollment

Outcomes

Duration of recurrence-free survival

Duration of overall survival
Cumulative incidences of vaginal recurrence, pelvic recurrence, distant (extra-pelvic) recurrence, and death from endometrial cancer
Toxicity as assessed by NCI CTCAE v3.0
Quality of life as assessed by the FACT-G Physical and Functional Well-Being, FACT-En, FACT/GOG-Ntx, FACIT-F, PROMIS Fatigue-SF1, and FACT-Cx questionnaires

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.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

D. Scott McMeekin, MD, Protocol chair		Ph: 405-271-8707
Marcus Randall, MD, Protocol co-chair		Ph: 859-257-7618

U.S.A.
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Clinical Trials Office - University of Chicago Cancer Research Center	Ph:  773-834-7424
Louisiana
	Baton Rouge
	Woman's Hospital
		Giles Fort, MD	Ph:  225-358-1071
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Eric Jenison, MD	Ph:  330-344-6041
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402

Related Information

PDQ® clinical trial GOG-0210

Registry Information
Official Title		A Phase III Trial of Pelvic Radiation Therapy Versus Vaginal Cuff Brachytherapy Followed By Paclitaxel/Carboplatin Chemotherapy in Patients with High Risk, Early Stage Endometrial Carcinoma
Trial Start Date		2009-03-23
Trial Completion Date		2013-03-01 (estimated)
Registered in ClinicalTrials.gov		NCT00807768
Date Submitted to PDQ		2008-12-04
Information Last Verified		2009-05-06
NCI Grant/Contract Number		CA27469