A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma
| City: |
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Willmar |
| State: |
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Minnesota |
| Zip Code: |
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56201 |
| Conditions: |
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Endometrial Cancer |
| Purpose: |
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RATIONALE: Drugs used in chemotherapy, such as carboplatin, paclitaxel, and cisplatin, work
in different ways to stop the growth of tumor cells, either by killing the cells or by
stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of
radiation to kill tumor cells. Giving chemotherapy and radiation therapy after surgery may
kill any tumor cells that remain after surgery. It is not yet known whether carboplatin and
paclitaxel are more effective with or without cisplatin and radiation therapy in treating
patients with endometrial cancer.
PURPOSE: This randomized phase III trial is studying carboplatin and paclitaxel to see how
well they work when given with or without cisplatin and radiation therapy in treating
patients with stage I, stage II, stage III, or stage IVA endometrial cancer.
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| Study Summary: |
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OBJECTIVES:
Primary
- Compare the recurrence-free survival of patients with stage I-IVA endometrial carcinoma
treated with adjuvant chemoradiotherapy comprising cisplatin and tumor volume-directed
radiotherapy followed by carboplatin and paclitaxel vs carboplatin and paclitaxel
alone.
Secondary
- Compare the overall survival of patients treated with these regimens.
- Compare the acute and late adverse effects of these regimens in these patients.
- Determine the impact of these regimens on patient-reported quality of life during and
for up to 1 year after completion of study treatment.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive cisplatin IV on days 1 and 29. Patients also undergo
external-beam radiotherapy once daily, 5 days a week, for 5-6 weeks. Some patients may
then undergo brachytherapy over 2-3 weeks. Beginning within 8 weeks after completion of
chemoradiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV on
day 1. Treatment repeats every 21 days for 4 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV on day 1.
Treatment repeats every 21 days for 6 courses in the absence of disease progression or
unacceptable toxicity.
Patients complete quality-of-life questionnaires at baseline and periodically during study
using the FACT-G Physical and Functional Well-Being, FACT-Endometrial, FACT/GOG Neuropathy,
and FACT-C (items C3 and C5).
After completion of study therapy, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed endometrial carcinoma, including the following cell types:
- Clear cell carcinoma
- Serous papillary carcinoma
- Undifferentiated carcinoma
- Surgical stage III or IVA disease per FIGO 2009 staging criteria
- Surgical stage III disease includes positive adnexa, tumor invading the serosa,
positive pelvic and/or para-aortic nodes, or vaginal involvement
- Surgical stage IVA disease includes bladder or bowel mucosal involvement, but no
spread outside the pelvis
- Surgical stage I or II endometrial clear cell or serous papillary carcinoma with
positive peritoneal cytology per FIGO 2009 staging criteria
- Has undergone optimal surgical debulking that included a hysterectomy and bilateral
salpingo-oophorectomy within the past 8 weeks
- Residual tumor after surgery (any single site) ≤ 2 cm in maximum dimension
- No carcinosarcoma
- No parenchymal liver metastases
- No recurrent endometrial cancer or endometrioid stage I or II with positive
peritoneal cytology
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/mm^3
- ANC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ ULN
- No myocardial infarction, unstable angina, or uncontrolled arrhythmia within the past
3 months
- No other active invasive malignancy within the past 5 years except for non-melanoma
skin cancer
- No history of serious co-morbid or uncontrolled illness that would preclude study
therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior pelvic or abdominal radiotherapy
- No prior chemotherapy for endometrial cancer
- No prior cancer treatment that would preclude study therapy
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| NCT ID: |
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NCT00942357 |
| Primary Contact: |
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Study Chair
Daniela E. Matei, MD
Indiana University Melvin and Bren Simon Cancer Center
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| Backup Contact: |
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N/A |
| Location Contact: |
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Willmar, Minnesota 56201
United States
Daniel M. Anderson
Phone: 320-231-4650
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 25, 2013 |
| Modifications to this listing: |
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