A Randomised Controlled Trial Between Two Different HDR Brachytherapy Schedule in Locally Advanced Carcinoma of Uterine Cervix
Study of Two Fractions Versus Three Fractions High Dose Rate Brachytherapy in Locally Advanced Carcinoma of Uterine Cervix After Pelvic Concurrent Chemoradiotherapy - a Randomized Controlled Trial
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to compare two different brachytherapy treatment option in locally advanced carcinoma of uterine cervix. Brachytherapy of two fractions of 9 Gy is effective in locoregional control and more convenient in terms of cost and time than 7 Gy brachytherapy of 3 fractions in management of locally advanced carcinoma of cervix.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2015
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
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 5, 2016
CompletedFirst Posted
Study publicly available on registry
May 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJuly 16, 2018
July 1, 2018
1.4 years
May 5, 2016
July 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of tumor size in cervix
Comparison of pre treatment tumor size with post treatment tumor
Six month
Study Arms (2)
Radiation HDR Brachytherapy 9 Gy
EXPERIMENTALHigh dose rate (HDR) Brachytherapy of weekly 9 Gray in two fractions in two weeks after 50 Gray of EBRT in 2 Gray per fraction of 5 weeks with chemotherapy cisplatin 40 mg /m2 weekly for five weeks in locally advanced carcinoma cervix
Radiation HDR Brachytherapy 7 Gy
ACTIVE COMPARATORHigh dose rate (HDR) brachytherapy of weekly 7 Gray in three fractions in three weeks after 50 Gray EBRT of 2 Gray per fraction of 25 fractions concurrently with weekly chemotherapy cisplatin40 mg /m2 in five weeks in locally advanced carcinoma cervix
Interventions
Two fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
Three fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
Eligibility Criteria
You may qualify if:
- Locally advanced carcinoma cervix (stage 2b - 4a)
- Histopathology squamous cell carcinoma
You may not qualify if:
- Previous history of malignancy
- Previously treated with radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BSM Medical University
Dhaka, 1200, Bangladesh
Related Publications (1)
Patel FD, Rai B, Mallick I, Sharma SC. High-dose-rate brachytherapy in uterine cervical carcinoma. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):125-30. doi: 10.1016/j.ijrobp.2004.09.017.
PMID: 15850912RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohammad Abdul Bari, MBBS,MPhil
Associate Professor,dept.of Oncology,BSMMU
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident,Dept. of Oncology,BSMMU
Study Record Dates
First Submitted
May 5, 2016
First Posted
May 9, 2016
Study Start
July 1, 2015
Primary Completion
December 1, 2016
Study Completion
July 1, 2017
Last Updated
July 16, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share