Brachytherapy treatment for cervical cancer using interstitial needles
Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes
This study is testing a new way to deliver high dose radiation treatment for cervical cancer using special needles to see if it is safe and effective for patients in an outpatient setting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 21 Years and up |
| Sex | Female |
| Sponsor | National University Hospital, Singapore Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06284031 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and safety of administering three fractions of high dose rate (HDR) brachytherapy with interstitial needles for patients with cervical cancer in an outpatient setting. It is a single-arm phase II prospective study that will recruit approximately 56 patients over three years at the National University Hospital. The primary objective is to assess clinical outcomes such as local control rates and overall survival, while secondary objectives focus on long-term toxicities associated with the treatment. Patients will undergo thorough pre-treatment assessments and receive tailored brachytherapy based on MRI evaluations.
Who should consider this trial
Good fit: Ideal candidates include women aged 21 and older with histologically confirmed cervical cancer stages IB to IVA.
Not a fit: Patients who have undergone surgery for cervical cancer or are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve local control and survival rates for patients with cervical cancer.
How similar studies have performed: While this approach is being evaluated in this specific context, similar brachytherapy techniques have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Singapore
- National University Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Vicky Koh, MD — National University Hospital, Singapore
- Study coordinator: Fatin Aliyah, BSc
- Email: fatin_hussin@nuhs.edu.sg
- Phone: +6581005851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.