Radiation + Chemotherapy for Endometrial Cancer
Recruiting in Palo Alto (17 mi)
+9 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: POLE mutations, Mismatch repair deficient, Inflammatory bowel disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to find out whether short-course radiation therapy (1 week instead of the usual 5 weeks) with chemotherapy (carboplatin and paclitaxel) is practical (feasible), meaning that most participants are able to complete the treatment schedule.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination of paclitaxel and carboplatin for endometrial cancer?
Research shows that the combination of paclitaxel and carboplatin is active against endometrial tumors, with a 67% overall response rate in patients with advanced or recurrent endometrial cancer. This combination has shown improved response rates compared to previous treatments, although the duration of response and long-term survival rates remain areas for further improvement.
12345Is the combination of radiation and chemotherapy with carboplatin and paclitaxel safe for humans?
Studies have shown that the combination of carboplatin and paclitaxel with radiation therapy has been evaluated for safety in various cancers, including lung, cervical, and endometrial cancer. These studies aimed to determine the safe dosage and identify any side effects, indicating that this treatment approach has been considered generally safe for humans, though side effects can occur.
678910How is the treatment of radiation and chemotherapy with carboplatin and paclitaxel unique for endometrial cancer?
This treatment combines intensity-modulated radiation therapy (IMRT) with chemotherapy drugs carboplatin and paclitaxel, which is unique because it uses advanced radiation techniques to precisely target cancer cells while minimizing damage to surrounding healthy tissue, and combines it with chemotherapy to enhance the overall effectiveness against advanced or high-risk endometrial cancer.
1271112Eligibility Criteria
This trial is for adults with newly diagnosed endometrial carcinoma who've had specific surgeries and have no residual disease. They must not be breastfeeding, have good organ function, and a performance status indicating they can care for themselves. Excluded are those with certain genetic markers or prior treatments, active infections needing antibiotics (except simple UTIs), or conditions that could affect the trial's safety or results.Inclusion Criteria
Participants must agree not to breastfeed during the study or for 150 days after the last dose of study treatment.
I have another cancer, but it won't affect this trial's treatment.
I am not on antibiotics for an infection, except for a simple UTI.
+17 more
Exclusion Criteria
Patients with psychiatric or substance use disorders that would interfere with cooperation with the requirements of the trial.
My endometrial cancer lacks certain proteins, confirmed by specific tests.
I am not suitable for pelvic radiation therapy.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive short-course radiation therapy for 1 week
1 week
Chemotherapy
Participants receive carboplatin and paclitaxel chemotherapy
6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
up to 3 years
Participant Groups
The study tests if a shorter radiation therapy course (1 week) combined with chemotherapy drugs carboplatin and paclitaxel is feasible for patients to complete compared to the usual 5-week radiation schedule. It aims to see if participants can stick to this condensed treatment plan without significant issues.
1Treatment groups
Experimental Treatment
Group I: Participants with Endometrial CancerExperimental Treatment3 Interventions
Participants have stage III endometrial cancer
Carboplatin is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Paraplatin for:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
🇪🇺 Approved in European Union as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
🇨🇦 Approved in Canada as Carboplatin for:
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Basking Ridge (All protocol activities)Basking Ridge, NJ
Memoral Sloan Kettering Monmouth (All protocol activities)Middletown, NJ
Memoral Sloan Kettering Westchester (All protocol activities)Harrison, NY
Memorial Sloan Kettering Monmouth (All protocol activities)Middletown, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
A trial of outpatient paclitaxel and carboplatin for advanced, recurrent, and histologic high-risk endometrial carcinoma: preliminary report. [2016]The purpose of this study was to evaluate the combination of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) and carboplatin in patients with endometrial cancer known to be resistant to standard therapy. Subjects were taken from three groups: (1) recurrent or persistent disease following surgery and/or radiation, (2) advanced disease at diagnosis, and (3) high-risk histology. The combination of carboplatin (pharmacologically dosed at an area under the concentration-time curve of 5) and paclitaxel (135 to 175 mg/m2 over 3 hours) was given intravenously every 4 weeks for eight courses. Data about response, overall and progression-free survival, and toxicity were collected. Response and toxicity were evaluated by physical examinations, x-ray films, and blood tests. Twenty patients have participated to date, including eight considered evaluable for response. Due to limited follow-up, survival and progression-free intervals are not yet assessable. Of patients with measurable disease, five of eight (63%) have had significant reduction in the size of evaluable tumor masses, constituting a partial response. Although two patients had clinical and radiographic complete responses, occult disease was found at surgery. There were no complete responders. Fifteen patients had grade 3 or 4 hematologic toxicity, but none had neutropenic fever or hospitalization for sepsis. One patient was taken off study for grade 3 neuropathy. There was one possible treatment-related death. In this preliminary report, this combination is active against tumors of the endometrium, with acceptable levels of toxicity. Further follow-up will be required to determine the duration of response and whether progression-free and overall survival are influenced by treatment with these drugs.
Concomitant paclitaxel plus carboplatin and radiotherapy for high-risk or advanced endometrial cancer. [2018]The objective of this study was to evaluate the outcome and feasibility of concurrent chemotherapy with paclitaxel plus carboplatin and radiotherapy (RT) in patients with high-risk or advanced endometrial cancer.
Dose dense carboplatin paclitaxel improves progression free survival in patients with endometrial cancer. [2022]Pilot study to assess the value of weekly paclitaxel plus carboplatin every 3weeks (dose dense regimen, DD) compared to the standard 3-weekly protocol in the adjuvant setting for endometrial cancer.
A phase II study of frontline paclitaxel/carboplatin/bevacizumab, paclitaxel/carboplatin/temsirolimus, or ixabepilone/carboplatin/bevacizumab in advanced/recurrent endometrial cancer. [2023]Paclitaxel and carboplatin (PC) is a standard initial therapy for advanced endometrial cancer. We evaluated the efficacy and tolerability of incorporating three novel agents into initial therapy.
Treatment of primary advanced and recurrent endometrial carcinoma with a combination of carboplatin and paclitaxel-long-term follow-up. [2018]There is no generally accepted standard chemotherapy in treatment of advanced and recurrent endometrial carcinoma. Cisplatin and doxorubicin with or without cyclophosphamide are widely used. Response rates have improved with combination chemotherapy compared with single-agent therapy. A platinum analog seems to be an important part of the chemotherapy regimen. Since few patients are cured from their disease and since the duration of response is short, further improvement of this therapy is warranted. During the past years, the taxanes (paclitaxel) are being added to prior evaluated regimens and not only improved response rates are reported but also increased toxicity is observed. In a prospective, phase II, multicenter study, carboplatin (area under the curve = 5) and paclitaxel (175 mg/m(2)) were evaluated in treatment of primary advanced and recurrent endometrial carcinoma. In total, 66 patients were recruited during the years 2000-2004. Eighteen primary advanced tumors and 48 recurrences were treated. All histologic types and tumor grades were allowed. The median follow-up was 57 months (range 37-69 months). The overall response rate was 67% (95% CI 55-78). The complete response rate was 29% and the partial response rate 38%. Primary advanced and recurrent tumors as well as endometrioid and nonendometrioid tumors showed similar response rates. The median response duration was 14 months. The 1- and 3-year survival rates were 82% and 33%, respectively. The main toxicities were hematologic and neurologic (sensory neuropathy). The response rates were encouraging, superior to prior platinum-containing regimens, but response duration and the long-term survival rate were still short. The neurologic toxicity was frequent and was a substantial problem in this series of patients. Further research is highly needed to improve the treatment of advanced and recurrent endometrial cancer.
[A phase I clinical trial of combination chemotherapy of paclitaxel with carboplatin and concurrent radiation therapy in locally advanced non-small cell lung cancer]. [2010]Based on superior results with combined-modality therapy in patients with advanced,unresectable non-small cell lung cancer (NSCLC),to evaluate the activity and toxicity of combination of paclitaxel with carboplatin and concurrent radiation therapy.
Concurrent carboplatin/paclitaxel and intravaginal radiation in surgical stage I-II serous endometrial cancer. [2021]To report a single institution experience in surgical stage I-II serous endometrial cancer using combined carboplatin/paclitaxel and intravaginal radiation (IVRT).
A phase I study of concurrent weekly carboplatin and paclitaxel combined with intensity-modulated pelvic radiotherapy as an adjuvant treatment for early-stage cervical cancer patients with positive pelvic lymph nodes. [2020]The objective of this study was to determine the maximum tolerated dose (MTD) and acute dose-limiting toxicities (DLTs) of intravenous carboplatin plus paclitaxel combined with intensity-modulated pelvic radiotherapy (pelvic IMRT) as an adjuvant treatment for early-stage cervical cancer patients with positive pelvic lymph nodes.
Treatment with paclitaxel plus carboplatin, alone or with irradiation, of advanced or recurrent endometrial carcinoma. [2015]The goal of this study was to evaluate the efficacy and toxicity of paclitaxel plus carboplatin in the treatment of primarily advanced or recurrent endometrial carcinoma.
A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study. [2018]A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer.
Postoperative external beam radiation therapy and concurrent cisplatin followed by carboplatin/paclitaxel for stage III (FIGO 2009) endometrial cancer. [2020]The optimal adjuvant therapy in advanced endometrial cancer is controversial. One regimen is concurrent external beam pelvic irradiation (RT) and cisplatin, then carboplatin/paclitaxel. This study reports an institutional experience using this approach in stage III (FIGO 2009) endometrial cancer.
A phase II evaluation of docetaxel and carboplatin followed by tumor volume directed pelvic plus or minus paraaortic irradiation for stage III endometrial cancer. [2018]To determine the feasibility and efficacy of administering docetaxel and carboplatin chemotherapy followed by tumor directed radiation in patients with advance stage endometrial cancer.