National University Hospital
Singapore, 119074
Location status: Recruiting
NCT Number: NCT06284031
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
Interested in participating?
Request Info21 year and older
Female
Interventional
Not applicable
Singapore, 119074
Location status: Recruiting
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2 years from time of recruitment
Percentage of patients who recurred at the site of the initial primary (the cervix).
Time frame: 2 years from time of recruitment
Percentage of patients who recurred in the pelvis or regional lymph nodes (not in cervix).
Time frame: 2 years from time of recruitment
Percentage of patients who develop first evidence of cancer recurrence.
Time frame: 2 years from time of recruitment
Percentage of patients who died from any cause
Time frame: 2 years from time of recruitment
To determine the long-term toxicities of this regimen based on CTCAE v5
Interested in participating?
Request InfoNational University Hospital, Singapore
Other
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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