Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 3 fractions HDR brachytherapy.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 21 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes
Overview
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.
Interventions
- Procedure 3 fractions HDR brachytherapy
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
Primary outcome measures
- Local control rate [Time frame: 2 years from time of recruitment]
- Loco-regional control rate [Time frame: 2 years from time of recruitment]
- Progression-free survival (PFS) [Time frame: 2 years from time of recruitment]
- Overall survival (OS) [Time frame: 2 years from time of recruitment]
Secondary outcome measures (1)
- Long term toxicities [Time frame: 2 years from time of recruitment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Post operative cervical cancer cases
- Pregnant or breastfeeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Singapore · 1 center
- National University Hospital — Singapore
Identifiers
NCT: NCT06284031 · Brachy Study