- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02765919
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cervical cancer is the second most common cancer among women worldwide and is the commonest form of gynecolgic malignancy in Bangladesh.Radiotherapy in the form of external beam radiotherapy combined with intracavitary Brachytherapy is the accepted definitive mode of treatment.Limiting the number of high dose rate(HDR) Brachytherapy has the potential benefit of improving patient compliance and reducing treatment cost and duration.The aim of this study is to compare the treatment outcome and acute complications following treatment with 9 Gray (Gy) in two fractions of brachytherapy with standard EBRT in locally advanced carcinoma of cervix.
EBRT will be delivered by a cobalt 60 teletherapy unit to a prescribed dose of 50 Gy in 25 fractions of 2 Gy per fraction and 5 days a week over a period of 5 weeks concurrent with inj. Cisplatin 40 mg/meter square weekly for 5 weeks.The patients will be then randomised into two arms of HDR brachytherapy,either 9Gy in 2 fractions or 7 Gy in 3 fractions.All patients will be followed up as per guideline for 6 months.The treatment related toxicity will be measured by Common Toxicity Criteria(Common terminology criteria for adverse events v.3.0).
All the relevant collected data will be compiled on a master chart and then statistical analysis of the results will be obtained by using SPSS 17.The data will be analysed using Chi square test and T test.Significant value will be decided at a level of 0.05 in two tailed tests.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh, 1200
- BSM Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Locally advanced carcinoma cervix (stage 2b - 4a)
- Histopathology squamous cell carcinoma
Exclusion Criteria:
- Previous history of malignancy
- Previously treated with radiotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radiation HDR Brachytherapy 9 Gy
High 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
|
Two fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
|
Active Comparator: Radiation HDR Brachytherapy 7 Gy
High 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
|
Three fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of tumor size in cervix
Time Frame: Six month
|
Comparison of pre treatment tumor size with post treatment tumor
|
Six month
|
Collaborators and Investigators
Investigators
- Study Director: Mohammad Abdul Bari, MBBS,MPhil, Associate Professor,dept.of Oncology,BSMMU
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
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
Other Study ID Numbers
- 1356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Squamous Cell Carcinoma of Cervix
-
Laboratorio Elea Phoenix S.A.CompletedSquamous Cell Carcinoma of the Cervix | Adenocarcinoma of the CervixArgentina
-
Kyunghee Burkitt, DO, PhDNot yet recruitingSquamous Cell Carcinoma of the Larynx | Squamous Cell Carcinoma of the Oral Cavity | HPV-Related Squamous Cell Carcinoma | Squamous Cell Carcinoma of the Oropharynx | Squamous Cell Carcinoma of the HypopharynxUnited States
-
Terrence JonesNestléCompletedLaryngeal Squamous Cell Carcinoma | Squamous Cell Carcinoma of Oropharynx | Squamous Cell Carcinoma of Mouth | Squamous Cell Carcinoma of the HypopharynxUnited Kingdom
-
University of Erlangen-Nürnberg Medical SchoolRecruitingSquamous Cell Carcinoma of the Larynx | Squamous Cell Carcinoma of the Oral Cavity | Squamous Cell Carcinoma of the Oropharynx | Squamous Cell Carcinoma of the HypopharynxGermany
-
Alberta Health servicesCompleted
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Head and Neck Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma of the Hypopharynx | Metastatic Squamous Cell Carcinoma of the Larynx | Metastatic Squamous Cell Carcinoma of the Oral Cavity | Metastatic Squamous Cell Carcinoma of the Oropharynx | Recurrent Hypopharyngeal... and other conditionsUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteBristol-Myers Squibb; Eli Lilly and Company; James and Esther King Biomedical...Active, not recruitingHead and Neck Squamous Cell Carcinoma | Head and Neck Carcinoma | Squamous Cell Carcinoma of the Larynx | Squamous Cell Carcinoma of the Oral Cavity | Squamous Cell Cancer | Squamous Cell Carcinoma of the Oropharynx | Squamous Cell Carcinoma of the Hypopharynx | Squamous Cell Carcinoma of the Paranasal...United States
-
Arbeitsgemeinschaft medikamentoese TumortherapieMedical University of GrazTerminatedLocally Advanced Malignant Neoplasm | Squamous Cell Carcinoma of the Hypopharynx Stage III | Squamous Cell Carcinoma of the Hypopharynx Stage IV | Squamous Cell Carcinoma of the Oral Cavity Stage III | Squamous Cell Carcinoma of the Oral Cavity Stage IV | Laryngeal Squamous Cell Carcinoma Stage... and other conditionsAustria
-
Arbeitsgemeinschaft medikamentoese TumortherapieCompletedSquamous Cell Carcinoma of the Hypopharynx Stage III | Squamous Cell Carcinoma of the Hypopharynx Stage IV | Squamous Cell Carcinoma of the Larynx Stage III | Squamous Cell Carcinoma of the Larynx Stage IV | Squamous Cell Carcinoma of the Oropharynx Stage III | Squamous Cell Carcinoma of the... and other conditionsAustria
-
Charite University, Berlin, GermanyCompletedSquamous Cell Carcinoma of the Neck | Squamous Cell Carcinoma of the HeadGermany
Clinical Trials on HDR Brachytherapy of 9 Gy in 2 fractions
-
Fundacao ChampalimaudCompleted
-
Canadian Cancer Trials GroupTrans Tasman Radiation Oncology GroupCompletedSpinal MetastasesCanada, Australia
-
University of SydneyNational Health and Medical Research Council, Australia; European Organisation... and other collaboratorsActive, not recruitingProstatic NeoplasmsUnited States, Australia, United Kingdom, Spain, New Zealand, Ireland, Austria, Belgium, Slovenia
-
William Beaumont HospitalsTerminatedAlzheimer's DiseaseUnited States
-
Memorial Sloan Kettering Cancer CenterUniversity of Pisa; University of California, San Francisco; The Champalimaud...Active, not recruitingMelanoma | Sarcoma | Ovarian Cancer | Bone | Soft Tissue | Lymph Nodes | CNS-Spinal CD/MEMBR, NOSUnited States, Italy, Portugal
-
University of Texas Southwestern Medical CenterCompletedProstate CancerUnited States
-
Fundacao ChampalimaudUnknownAdenocarcinoma of the ProstatePortugal
-
Centre hospitalier de l'Université de Montréal...Terminated
-
King Faisal Specialist Hospital & Research CenterRadiation Therapy Oncology GroupCompletedMalignant Salivary Gland TumorsSaudi Arabia
-
University Hospital, BordeauxActive, not recruiting