- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03189446
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
Study Overview
Status
Intervention / Treatment
Detailed Description
Before the patient begins the study:
Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.
Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care.
Treatment:
All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy.
Study participation will be up to two years.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Stephenson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory.
- Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional.
- If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed.
All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
- age ≥18 years with 3 risk factors
Risk factors:
- Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology.
- Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors.
- Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement).
- Patients must have GOG performance status 0, 1, or 2.
- Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol.
- Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Exclusion Criteria:
- Patients with recurrent disease.
- Patients with GOG performance status of 3 or 4.
- Greater than 12 weeks elapsed from surgery to enrollment.
- Patients have prior pelvic or abdominal radiation therapy.
- Known hypersensitivity to any component of study treatment that resulted in drug discontinuation.
- Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- Active pregnancy or lactation.
- Prior malignancy requiring treatment within the last 3 years.
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: Vaginal Cuff Brachytherapy + Chemotherapy
Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles
|
Within 12 weeks of surgery.
Either LDR or HDR brachytherapy will be permitted
Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Completing the Protocol
Time Frame: 4 months
|
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of Adverse Events Related to Acute Toxicity During Treatment
Time Frame: 4 months
|
Frequency and severity of adverse events as assessed by the CTCAE v4
|
4 months
|
Recurrence-free Survival
Time Frame: up to 2 years
|
time from study entry to the first tumor recurrence
|
up to 2 years
|
Contributing Cause of Death
Time Frame: up to 2 years
|
The contributing cause of death for patients with high risk endometrial cancer
|
up to 2 years
|
Overall Survival
Time Frame: up to 2 years
|
time from study entry to death
|
up to 2 years
|
Sites of Failure
Time Frame: up to 2 years
|
Proportion of participants who experienced failure in regional or distant sites
|
up to 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathleen Moore, MD, Stephenson Cancer 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 (Actual)
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
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Endometrial Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- 7964
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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 Endometrial Cancer
-
Assistance Publique - Hôpitaux de ParisUniversité Montpellier; Ecole d'econmie de Paris (PSE)-Hospinnomics; Université...CompletedEndometrial Cancer Stage I | Endometrial Cancer Stage IIFrance
-
Radboud University Medical CenterMaastricht University Medical Center; Erasmus Medical Center; Catharina Ziekenhuis... and other collaboratorsRecruitingEndometrial Cancer Recurrent | Endometrial Cancer Stage III | Endometrial Cancer Stage IVNetherlands
-
Batman Training and Research HospitalEskisehir Osmangazi UniversityCompletedGynecologic Cancer | Endometrial Cancer Stage
-
Samsung Medical CenterRecruitingEndometrial Cancer Stage IKorea, Republic of
-
Duke UniversityDuke Cancer InstituteCompleted
-
Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.RecruitingAdvanced Endometrial CancerChina
-
Novartis PharmaceuticalsCompletedAdvanced Endometrial CancerBelgium, France, Italy, Canada, Spain, Australia, Germany, United States, Japan, Brazil, Singapore, Russian Federation, Poland
-
Rambam Health Care CampusCompletedSerous Papillary Endometrial CancerIsrael
-
Masonic Cancer Center, University of MinnesotaCompletedCervical Cancer | Ovarian Cancer | Uterine Endometrial CancerUnited States
Clinical Trials on Vaginal Cuff Brachytherapy
-
University of UtahRecruitingStage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Endometrial Clear Cell Adenocarcinoma | Endometrial Endometrioid Adenocarcinoma | Endometrial Serous Adenocarcinoma | Uterine Corpus Sarcoma | Uterine Corpus Carcinosarcoma | Stage IA Uterine Corpus Cancer | Stage IB Uterine Corpus CancerUnited States
-
Xoft, Inc.CompletedEndometrial CancerUnited States
-
University of OklahomaCompletedEndometrial Cancer | Papillary Serous | Clear Cell Endometrial CancerUnited States
-
Walter Reed National Military Medical CenterUnknown
-
Bridgeport HospitalCompleted
-
Canadian Cancer Trials GroupCanadian Cancer Clinical Trials NetworkRecruitingEndometrial CancerCanada, Australia, Netherlands
-
Cairo UniversityUnknown
-
Kara Romano, MDRecruiting
-
Kanuni Sultan Suleyman Training and Research HospitalActive, not recruiting
-
Brigham and Women's HospitalCompletedClosure of Vaginal Cuff at Laparoscopic HysterectomyUnited States