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Trial Title:
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions
NCT ID:
NCT06284031
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
3 fractions HDR brachytherapy
Description:
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
Arm group label:
3 fractions
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 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
1. Case reviewed in gynae multidisciplinary meeting
2. Detailed gynaecologic assessment on diagnosis
3. Staging scan - MRI pelvis, CT TAP or PET CT
4. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 21 years old and above
2. Histologically proven squamous cell carcinoma, adenocarcinoma, adenosquamous or
poorly differentiated cervical cancer
3. Clinically or radiologically stage IB - IVA cervical cancer based on TNM 8th Edition
4. ECOG performance status 0, 1, or 2
5. To complete external beam radiotherapy and brachytherapy in NUH
6. Written, voluntary informed consent
7. Patients must be accessible for follow up and management in NUH
Exclusion Criteria:
1. Post operative cervical cancer cases
2. Pregnant or breastfeeding women
Gender:
Female
Gender based:
Yes
Gender description:
As cervical cancer patients are females, we will only be recruiting female patients.
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Zip:
119074
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Fatin Aliyah, BSc
Phone:
+6581005851
Email:
fatin_hussin@nuhs.edu.sg
Investigator:
Last name:
Syadwa Abdul Shukor, MD
Email:
Sub-Investigator
Investigator:
Last name:
Yiat Horng Leong, MD
Email:
Sub-Investigator
Investigator:
Last name:
Shing Fung Lee, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michelle Tseng, MD
Email:
Sub-Investigator
Start date:
June 26, 2023
Completion date:
December 2026
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06284031
