Cervical CancerNCT06284031
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions
A study testing 3 fractions HDR brachytherapy in people with Cervical Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- 3 fractions HDR brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Jun 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 21 years old and above
- Histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or poorly differentiated cervical cancer
- Clinically or radiologically stage IB - IVA cervical cancer based on TNM 8th Edition
- ECOG performance status 0, 1, or 2
- To complete external beam radiotherapy and brachytherapy in NUH
- Written, voluntary informed consent
- Patients must be accessible for follow up and management in NUH
Who cannot join
- Post operative cervical cancer cases
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Fatin Aliyah, BSc, +6581005851, fatin_hussin@nuhs.edu.sg
Syadwa Abdul Shukor, MD
About this study
Official title: Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes
Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting
Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)
Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5
Read the detailed description
This study is designed as a single arm phase II prospective study that will be open for recruitment for approximately 3 years. An estimated 56 cervical cancer patients treated in NUH will be recruited.
Pre-treatment Assessment
- Case reviewed in gynae multidisciplinary meeting
- Detailed gynaecologic assessment on diagnosis
- Staging scan - MRI pelvis, CT TAP or PET CT
- Baseline blood result - Full blood count, renal panel, liver panel, coagulation profile and Group screen and match
Treatment
All patients will be registered and reviewed in NUH Radiotherapy Centre. Written consent will be obtained if patient is agreeable to be recruited.
Brachytherapy A pre-brachytherapy planning magnetic resonance imaging (MRI) scan is performed to evaluate the response and extent of the parametrial involvement if any, as well as to determine the ideal placement of interstitial needles to achieve optimal coverage. The applicator to be used should be chosen prior to BT if possible. Twenty-four hours prior to the procedure, oral fleet is given to the patient to ensure adequate bowel preparation.
The 3 fractions of HDR brachytherapy may be delivered in the following ways:
Option 1: 3 insertions over 2 non-consecutive days:
9 Gy to the HRCTV in the first fraction on day 1 of the brachytherapy procedure and 7 Gy x 2 fractions at least 6 hours apart on day 2, retaining the same brachytherapy applicators of the second insertion for the final fraction.
Option 2: 3 insertions over 3 non-consecutive days 8Gy to the HRCTV per fraction per day for 3 non-consecutive days. Acute and late radiation toxicities will be scored according to Common Terminology Criteria for Adverse Events (CTCAE), version 5 Patients will be followed up at 1 month with a physical examination and with an MRI of the cervix within 3 months post procedure.
Patients will subsequently be followed up every 3 monthly with vaginal examination for the next 2 years. At each follow-up, toxicity will be recorded as per the CTCAE.
- Conditions
- Cervical Cancer
- Being tested
- 3 fractions HDR 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.
3 fractions HDR brachytherapyProcedure or surgery
The 3 fractions of HDR brachytherapy may be delivered in the following ways:
Option 1: 3 insertions over 2 non-consecutive days:
Option 2: 3 insertions over 3 non-consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 3 fractions | Experimental | Not described Receives: Procedure: 3 fractions HDR brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control rate
Percentage of patients who recurred at the site of the initial primary (the cervix).
Measured: 2 years from time of recruitment
Loco-regional control rate
Percentage of patients who recurred in the pelvis or regional lymph nodes (not in cervix).
Measured: 2 years from time of recruitment
Progression-free survival (PFS)
Percentage of patients who develop first evidence of cancer recurrence.
Measured: 2 years from time of recruitment
Overall survival (OS)
Percentage of patients who died from any cause
Measured: 2 years from time of recruitment
Secondary outcomes (1)
Long term toxicities
To determine the long-term toxicities of this regimen based on CTCAE v5
Measured: 2 years from time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start26 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vicky Koh, MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284031
- Sponsor's protocol ID
- Brachy Study
- Status last verified
- Aug 2023
- First submitted
- 25 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT06284031
- Acronym / sponsor ID
- Brachy Study
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Feb 2024 (actual)
- 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.
Aim To determine the feasibility and safety of 3 fractions of high dose rate (HDR) brachytherapy with interstitial needles for cervical cancer in the outpatient setting
Primary objective To determine the clinical outcome (2-yr local control rate, loco-regional control rate, progression free survival and overall survival)
Secondary objective To determine the long-term toxicities of this regimen based on CTCAE v5
Detailed description
This study is designed as a single arm phase II prospective study that will be open for recruitment for approximately 3 years. An estimated 56 cervical cancer patients treated in NUH will be recruited.
Pre-treatment Assessment
- Case reviewed in gynae multidisciplinary meeting
- Detailed gynaecologic assessment on diagnosis
- Staging scan - MRI pelvis, CT TAP or PET CT
- Baseline blood result - Full blood count, renal panel, liver panel, coagulation profile and Group screen and match
Treatment
All patients will be registered and reviewed in NUH Radiotherapy Centre. Written consent will be obtained if patient is agreeable to be recruited.
Brachytherapy A pre-brachytherapy planning magnetic resonance imaging (MRI) scan is performed to evaluate the response and extent of the parametrial involvement if any, as well as to determine the ideal placement of interstitial needles to achieve optimal coverage. The applicator to be used should be chosen prior to BT if possible. Twenty-four hours prior to the procedure, oral fleet is given to the patient to ensure adequate bowel preparation.
The 3 fractions of HDR brachytherapy may be delivered in the following ways:
Option 1: 3 insertions over 2 non-consecutive days:
9 Gy to the HRCTV in the first fraction on day 1 of the brachytherapy procedure and 7 Gy x 2 fractions at least 6 hours apart on day 2, retaining the same brachytherapy applicators of the second insertion for the final fraction.
Option 2: 3 insertions over 3 non-consecutive days 8Gy to the HRCTV per fraction per day for 3 non-consecutive days. Acute and late radiation toxicities will be scored according to Common Terminology Criteria for Adverse Events (CTCAE), version 5 Patients will be followed up at 1 month with a physical examination and with an MRI of the cervix within 3 months post procedure.
Patients will subsequently be followed up every 3 monthly with vaginal examination for the next 2 years. At each follow-up, toxicity will be recorded as per the CTCAE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3 fractions | Experimental | Procedure: 3 fractions HDR brachytherapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 21 years old and above
- Histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or poorly differentiated cervical cancer
- Clinically or radiologically stage IB - IVA cervical cancer based on TNM 8th Edition
- ECOG performance status 0, 1, or 2
- To complete external beam radiotherapy and brachytherapy in NUH
Key exclusion criteria (2 listed)
- Post operative cervical cancer cases
- Pregnant or breastfeeding women
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 |
|---|---|---|
| 3 fractions HDR brachytherapyThe 3 fractions of HDR brachytherapy may be delivered in the following ways: Option 1: 3 insertions over 2 non-consecutive days: Option 2: 3 insertions over 3 non-consecutive days | Procedure or surgery | 3 fractions |
Primary outcome
Local control rate
Time frame: 2 years from time of recruitment
Percentage of patients who recurred at the site of the initial primary (the cervix).
Loco-regional control rate
Time frame: 2 years from time of recruitment
Percentage of patients who recurred in the pelvis or regional lymph nodes (not in cervix).
Progression-free survival (PFS)
Time frame: 2 years from time of recruitment
Percentage of patients who develop first evidence of cancer recurrence.
Overall survival (OS)
Time frame: 2 years from time of recruitment
Percentage of patients who died from any cause
1 secondary outcome
Long term toxicities
Time frame: 2 years from time of recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- 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.
Vicky Koh, MD principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 fractions HDR brachytherapy in people with Cervical Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 7 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: looking for participants now, as of the sponsor's last update on 28 Feb 2024. 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 Singapore. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatin Aliyah, BSc (+6581005851, fatin_hussin@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control rate (time frame: 2 years from time of recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.