Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer
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
1 other identifier
interventional
23
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Sep 2007
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 11, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedResults Posted
Study results publicly available
September 27, 2017
CompletedAugust 21, 2020
August 1, 2020
8.4 years
October 10, 2007
April 14, 2017
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients With Progression-free Survival at 2 Years
2 years
Secondary Outcomes (1)
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy
2 years
Study Arms (1)
Vaginal Cuff Brachytherapy
EXPERIMENTALInterventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with recurrent disease.
- Patients with GOG performance status of 3 or 4.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Landrum, MD
- Organization
- University of Oklahoma
Study Officials
- PRINCIPAL INVESTIGATOR
Scott McMeekin, MD
University of Oklahoma
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
September 1, 2007
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
August 21, 2020
Results First Posted
September 27, 2017
Record last verified: 2020-08