Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer (NCT01367301) | Clinical Trial Compass
TerminatedNot Applicable
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
Stopped: Lack of accrual. PI left the institution
United States14 participantsStarted 2011-07-08
Plain-language summary
This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays 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 stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Recurrence-free Survival
Timeframe: Date of entry to date of reappearance of disease, assessed at 1 year