Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation
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|ClinicalTrials.gov Identifier: NCT04030000|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : March 16, 2020
Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial carcinoma that has poor response to standard therapy. After staging and surgery, radiation therapy and/or chemotherapy is recommended to treat patients at high risk for recurrence. In advanced stage and recurrent setting, high risk uterine cancer mirrors ovarian cancer with it spread patterns and response to therapy. Based on these findings and the similarities as well as the clinical success of paclitaxel with IP platinum therapy in patients with ovarian serous carcinoma, investigators propose to prospectively assess IV/IP therapy in patients with advanced stage and recurrent USC.
During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.
Patients will be monitored for toxicity and feasibility of the regimen. Secondary outcomes will include assessing the frequency and the reasons for early discontinuation of the study treatments as well as describing patient-reported quality of life parameters at specified time points during the study using validated questionnaires: EORTC QLQ-C30 and QLQ-OV28.
|Condition or disease||Intervention/treatment||Phase|
|Uterine Carcinoma||Drug: Paclitaxel/Carboplatin Radiation: Pelvic radiation therapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin/Taxol Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||August 2022|
Paclitaxel/Carboplatin and radiation
Paclitaxel 135 mg/m2 over 3 hrs on day 1 Carboplatin IP (AUC= 6.0) on day 1 Paclitaxel 60 mg/m2 IP on Day 8 Repeat q 21 days x 6 cycles
Pelvic 6MV Photon Beam Energy, or IMRT where appropriate 1.8 Gy Dose/FX Total Dose 45 Gy
High Dose Radiation (HDR) x 3, or IMRT where appropriate 5 Gy to 0.5cm Depth from the Vaginal Cylinder Surface Total Dose 15 Gy
IV paclitaxel in combination with IP carboplatin
Radiation: Pelvic radiation therapy
EBRT and vaginal brachytherapy
- Incidence of Treatment-related Adverse Events [ Time Frame: 2 years post diagnosis ]Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
- Feasibility of above regimen in women with advanced stage USC [ Time Frame: 2 years post diagnosis ]Feasibility will be assessed by: Treatment completion proportion - the proportion of participants who complete the IV paclitaxel/IP carboplatin followed by IP paclitaxel/RT regimen Screening ratio - the number of potential participants screened per enrolled participant
- Patient quality of life [ Time Frame: Baseline (after surgery, prior to initiating first cycle), Completion of chemotherapy (18 weeks after Cycle 1 Day 1),Completion of radiation therapy (26 weeks after Cycle 1 Day), Two years post diagnosis ]The questionnaires used are EORTC QLQ-C30. QOL will be assessed using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) version 3.0. To date, more than 2200 studies using QLQ-C30 have been registered. This 30-item summary score captures the dimension of physical well-being, functional well-being, and symptom scales.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030000
|Contact: Arisa Kapedani, MSemail@example.com|