| Conditions: |
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Endometrial Cancer - Fatigue - Neurotoxicity |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00807768 |
| Primary Contact: |
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Study Chair
D. Scott McMeekin, MD
Oklahoma University Cancer Institute
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| Backup Contact: |
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N/A |
| Location Contact: |
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Newark, Delaware 19713
United States
Clinical Trial Office - CCOP - Christiana Care Health Services
Phone: 302-623-4450
Site Status: Recruiting |