Squamous Cell Carcinoma of CervixPhase 3NCT02765919
A Randomised Controlled Trial Between Two Different HDR Brachytherapy Schedule in Locally Advanced Carcinoma of Uterine Cervix
A Phase 3 study testing HDR Brachytherapy of 9 Gy in 2 fractions and HDR Brachytherapy of 7 Gy in 3 fractions in people with Squamous Cell Carcinoma of Cervix, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Squamous Cell Carcinoma of Cervix
- What is being tested?
- HDR Brachytherapy of 9 Gy in 2 fractions and HDR Brachytherapy of 7 Gy in 3 fractions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2015to Jul 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Locally advanced carcinoma cervix (stage 2b - 4a)
- Histopathology squamous cell carcinoma
Who cannot join
- Previous history of malignancy
- Previously treated with radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Squamous Cell Carcinoma of Cervix
- Being tested
- HDR Brachytherapy of 9 Gy in 2 fractions, HDR Brachytherapy of 7 Gy in 3 fractions
- Keywords
- Carcinoma cervix, RCT(randomised controlled trial), 9 Gray, Brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR Brachytherapy of 9 Gy in 2 fractionsRadiation
Two fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
HDR Brachytherapy of 7 Gy in 3 fractionsRadiation
Three fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
| Study group | Role | What they receive |
|---|---|---|
| Radiation HDR Brachytherapy 9 Gy | Experimental | 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 Receives: Radiation: HDR Brachytherapy of 9 Gy in 2 fractions |
| Radiation HDR Brachytherapy 7 Gy | Active comparator | 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 Receives: Radiation: HDR Brachytherapy of 7 Gy in 3 fractions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of tumor size in cervix
Comparison of pre treatment tumor size with post treatment tumor
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of CervixStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Israt Jahan, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Mohammad Abdul Bari, MBBS,MPhil, Study director, Associate Professor,dept.of Oncology,BSMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765919
- Sponsor's protocol ID
- 1356
- Status last verified
- Jul 2018
- First submitted
- 5 May 2016
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 15850912
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02765919
- Acronym / sponsor ID
- 1356
- Conditions
- Squamous Cell Carcinoma of Cervix
- Keywords
- Carcinoma cervix, RCT(randomised controlled trial), 9 Gray, Brachytherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 9 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiation HDR Brachytherapy 9 Gy | Experimental | Radiation: HDR Brachytherapy of 9 Gy in 2 fractionsHigh 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 comparator | Radiation: HDR Brachytherapy of 7 Gy in 3 fractionsHigh 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Locally advanced carcinoma cervix (stage 2b - 4a)
- Histopathology squamous cell carcinoma
Key exclusion criteria (2 listed)
- Previous history of malignancy
- Previously treated with radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HDR Brachytherapy of 9 Gy in 2 fractionsTwo fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix | Radiation | Radiation HDR Brachytherapy 9 Gy |
| HDR Brachytherapy of 7 Gy in 3 fractionsThree fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix | Radiation | Radiation HDR Brachytherapy 7 Gy |
Primary outcome
Reduction of tumor size in cervix
Time frame: Six month
Comparison of pre treatment tumor size with post treatment tumor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Results publication: PubMed 15850912Patel 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Abdul Bari, MBBS,MPhil study director
Associate Professor,dept.of Oncology,BSMMU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HDR Brachytherapy of 9 Gy in 2 fractions and HDR Brachytherapy of 7 Gy in 3 fractions in people with Squamous Cell Carcinoma of Cervix, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of tumor size in cervix (time frame: Six month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02765919, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.