Efficacy Study of Chemotherapy Followed by Radiation Therapy to Treat Endometrial Cancer
A Phase II Trial of Docetaxel/Cisplatin Chemotherapy Followed by Pelvic Radiation Therapy in Patients, With High-risk Endometrial Carcinoma After Staging Surgery
1 other identifier
interventional
67
1 country
1
Brief Summary
Previous some studies suggested the addition of chemotherapy to radiation therapy after surgery may have survival benefit in patients with high risk endometrial cancer. In addition, docetaxel plus cisplatin regimen may have similar efficacy with paclitaxel plus carboplatin which is currently used in most cases. However, docetaxel plus cisplatin may cause less toxicity compared to paclitaxel plus carboplatin. Therefore, the investigators aimed to analyze the efficacy of docetaxel plus cisplatin regimen followed by radiation therapy after surgery in patients with high risk endometrial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2011
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 24, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 31, 2017
May 1, 2017
6.2 years
October 24, 2011
May 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival
2 years after completion of study treatment
Secondary Outcomes (3)
Overall survival
2 years after completion of study treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Before each chemotherapy, an expected average of 3 weeks
Quality of life
3 months after completion of study treatment
Study Arms (1)
Chemotherpay and radiation therapy
EXPERIMENTALDocetaxel plus cisplatin followed by radiation therapy
Interventions
Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
Eligibility Criteria
You may qualify if:
- One of following high risk groups Stage III after staging operation Stage II (Type I hysterectomy + BSO + LND) Stage I + two of \[Grade III, LVSI+, Mm\>1/2\] Clear cell or serous carcinoma: stage IB-II
- Age: 20-75
- ECOG PS: 0-2
- Adequate organ function BM: WBC ≥ 3,000/mm3, ANC≥1,500/mm3, Plt≥100X103/mm3, Hb≥10.0 g/dl Kidney: Creatinine \<1.25 × UNL이고, GFR ≥ 60 Liver: AST, ALT\< 3×UNL, T- bil\<1.5 mg/ mm3
- Informed Consent
You may not qualify if:
- Previous chemotherapy or pelvic RT
- Hormone therapy within 4 weeks
- Other malignant disease
- Uncontrolled medical disease
- Infection requiring antibiotics
- Symptomatic CHF, RF, Angina, Arrhythmia, etc.
- Neurosis or psychosis
- Etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Asan Medical Centerlead
- Boryung Pharmaceutical Co., Ltdcollaborator
Study Sites (1)
Asan Medical Center
Seoul, 138-736, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joo-Hyun Nam, M.D., Ph.D.
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2011
First Posted
October 28, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
May 31, 2017
Record last verified: 2017-05