- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01367301
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.
II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.
III. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.
OUTLINE:
CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22.
RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10461
- Albert Einstein College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Histologically documented uterine carcinosarcoma with no visible residual disease
- Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings
- Patients must be entered no more than 12 weeks post operatively
- Eastern Cooperative Oncology Group (ECOG) performance status of < 2
- Written voluntary informed consent
Exclusion Criteria:
- Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional upper limit of normal
- Total serum bilirubin > 1.5 mg/dl
- History of chronic or active hepatitis
- Serum creatinine > 2.0 mg/dl
- Platelets < 100,000/mm3
- Absolute neutrophil count (ANC) < 1500/mm3
- Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)
- Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
- Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
- Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
- Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (paclitaxel, carboplatin, radiotherapy)
CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16. |
Correlative studies
Given IV
Other Names:
Undergo IMRT
Other Names:
Given IV
Other Names:
Undergo external beam radiation therapy
Other Names:
Undergo HDR brachytherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence-free Survival
Time Frame: Date of entry to date of reappearance of disease, assessed at 1 year
|
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
|
Date of entry to date of reappearance of disease, assessed at 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Merieme Klobocista, Albert Einstein College of Medicine
- Principal Investigator: Dennis Yi-Shin Kuo, Montefiore Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Uterine Diseases
- Neoplasms, Complex and Mixed
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Sarcoma
- Carcinosarcoma
- Mixed Tumor, Mullerian
- Uterine Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 11-02-064 (Other Identifier: Albert Einstein College of Medicine)
- P30CA013330 (U.S. NIH Grant/Contract)
- 10-089 (St Luke's Roosevelt)
- NCI-2013-01225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uterine Carcinosarcoma
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Fondazione Policlinico Universitario Agostino Gemelli...CompletedCarcinosarcoma, Ovarian | Carcinosarcomas UterineItaly
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National Cancer Institute (NCI)Gynecologic Oncology GroupCompletedRecurrent Uterine Corpus Sarcoma | Uterine CarcinosarcomaUnited States
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National Cancer Institute (NCI)CompletedUterine Carcinosarcoma | Recurrent Uterine Sarcoma | Stage III Uterine Sarcoma | Stage IV Uterine SarcomaUnited States, Canada
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