| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Endometrial Cancer |
| Purpose: |
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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill
tumor cells. Drugs used in chemotherapy, such as cisplatin, 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 giving radiation therapy together with cisplatin is more effective
than radiation therapy alone in treating patients with endometrial cancer.
PURPOSE: This randomized phase II trial is studying radiation therapy and cisplatin to see
how well they work compared with radiation therapy alone in treating patients with recurrent
endometrial cancer.
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| Study summary: |
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OBJECTIVES:
Primary
- Determine whether pelvic radiotherapy and cisplatin are more promising with respect to
progression-free survival than pelvic radiotherapy alone in patients with recurrent
endometrial cancer limited to the pelvis and vagina.
Secondary
- Compare the sites of recurrence in patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the prognostic significance of the location (central pelvis versus vagina) and
size of the recurrence, in addition to the prognostic significance in the salvage
setting, in terms of histological subtype, grade, age, race, performance status, and
the presence of lymph-vascular space involvement of the original tumor at the time of
initial hysterectomy, in patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
treatment arms.
- Arm I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis on days 1-5,
8-12, 15-19, 22-26, 29-33, and 36-40. After completion of EBRT, patients undergo
intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate
interstitial brachytherapy*.
- Arm II: Patients undergo EBRT as in arm I and receive cisplatin IV over 1-2 hours on
days 1, 8, 15, 22, 29, and 36. Patients then undergo brachytherapy* as in arm I.
NOTE: *IMRT boost is allowed for patients who are not candidates for brachytherapy.
In both arms, treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed monthly for 3 months, every 3
months for 2 years, and then every 6 months for 3 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of endometrial cancer, including the following
histological subtypes:
- Adenocarcinoma
- Adenocarcinoma with squamous differentiation
- Mucinous adenocarcinoma
- Squamous cell carcinoma
- Mixed carcinoma
- Undifferentiated carcinoma
- Clear cell adenocarcinoma
- Serous adenocarcinoma
- Must have undergone prior complete hysterectomy and bilateral salpingo-oophorectomy
at the time of original therapy
- Recurrent disease confined to the pelvis and/or vagina
- No evidence of extrapelvic disease, including positive periaortic or
inguino-femoral nodes by chest x-ray or CT scan
- Prior primary surgical debulking (including removal of gross symptomatic disease in
the pelvis and/or vagina) allowed provided there is residual disease that is
evaluable clinically and/or by CT scan or MRI
- Patients who have undergone prior complete surgical resection of the recurrent
tumor and have no evidence of residual disease evaluable clinically and by CT
scan or MRI after resection are not eligible
- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement
prior to study entry
PATIENT CHARACTERISTICS:
- GOG performance status 0-2
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- 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 sensory or motor neuropathy > grade 1
- No septicemia or severe infection
- No circumstances that would preclude study participation
- No renal abnormalities (i.e., pelvic kidney, horseshoe kidney, or prior renal
transplantation) that would require modification of radiation fields
- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
- No significant history of cardiac disease, including uncontrolled hypertension,
unstable angina, congestive heart failure, or uncontrolled arrhythmias within the
past 6 months
- No history of active collagen vascular disease
PRIOR CONCURRENT THERAPY:
- At least 6 months since prior hormone therapy and/or systemic chemotherapy
- No prior neoadjuvant chemotherapy for recurrent disease
- No prior exenterative surgery
- No prior vaginal, pelvic, or abdominal irradiation
- No prior chemotherapy directed at the present recurrent disease
- No prior cancer treatment that would preclude study treatment |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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