At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed uterine papillary serous carcinoma with no visible residual disease
- ✓Prior surgical staging with hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node sampling
- ✓Age over 18 years
- ✓ECOG performance status <2
- ✕Prior chemotherapy or radiotherapy for pelvic malignancy
- ✕Myelosuppressive chemotherapy within 3 weeks prior to study entry
- ✕Severe or uncontrolled concurrent medical disease (uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure)
- ✕Dementia or altered mental status prohibiting informed consent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma
In Brief
A Phase 2 clinical trial evaluating Carboplatin and Paclitaxel and Pelvic Radiation Therapy and Carboplatin and Paclitaxel and Radiation Therapy for Uterine Cancer. Completed, enrolled 81 participants across 1 site.
Detailed Summary
Combination chemo/radiotherapy trials in advanced/recurrent endometrial cancer are ongoing. The optimal radiation modality, chemotherapeutic agents, and sequence of these regimens for the treatment of UPSC are yet to be established. A retrospective review of 16 patients treated at our institution with the sequential use of radiation "sandwiched" between paclitaxel/platinum chemotherapy found only one patient to have recurred at 16 months with a median follow-up of 15 months (range 6-33 months). The regimen was well tolerated. Eight of the sixteen patients (50%) developed grade 3 neutropenia following cycle 4 of chemotherapy, two of which required a 1 week treatment delay. There were no cases of grade 3 or 4 thrombocytopenia noted. There was no febrile neutropenia and no hospital admissions for toxicity. There were no observed grade 3 or 4 non-hematologic toxicities. With the median follow up of 15 months, we have not observed late toxicities. Given these favorable preliminary findings, supported by recently published data documenting efficacy of the "sandwich" multimodality technique in other difficult uterine malignancies (malignant mixed mullerian tumors), we propose to study this combination of chemotherapy and radiation prospectively. Our aim is to better evaluate patterns of recurrence and possible benefits in progression-free and overall survival.
Study Details
Timeline
Interventions
Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles