- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00542490
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
August 7, 2020 updated by: University of Oklahoma
Phase II Trial of Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy in Patients With Stage I-IIb Papillary Serous, Clear Cell and Endometrioid Endometrial Cancer With High-Intermediate Risk Factors
The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy.
All patients will receive radiation therapy.
Treatment will be delivered either by LDR or HDR brachytherapy.
The treatment plan must be started at the time of enrollment.
The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21.
The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators.
Following vaginal cuff radiation therapy, all patients will receive chemotherapy.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- University of Oklahoma Health Sciences Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- All patients must have undergone specified complete surgical staging.
- Patients must be surgically staged endometrial cancer patients at high-risk for recurrence.
- Patients must have adequate bone marrow, renal and hepatic function.
Exclusion Criteria:
- Patients with recurrent disease.
- Patients with GOG performance status of 3 or 4.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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
|
Clinical stage I-II endometrial cancer surgically staged.
Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Patients With Progression-free Survival at 2 Years
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott McMeekin, MD, University of Oklahoma
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
October 10, 2007
First Submitted That Met QC Criteria
October 10, 2007
First Posted (Estimate)
October 11, 2007
Study Record Updates
Last Update Posted (Actual)
August 21, 2020
Last Update Submitted That Met QC Criteria
August 7, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1524
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
-
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
-
Samsung Medical CenterRecruitingEndometrial Cancer Stage IKorea, Republic of
-
Duke UniversityDuke Cancer InstituteCompleted
-
Far Eastern Memorial HospitalCompletedOutcome of Endometrial CancerTaiwan
-
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
-
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
-
Kanuni Sultan Suleyman Training and Research HospitalActive, not recruiting