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NCT Number: NCT06284031

Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions

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

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

Location status: Recruiting

Location contact

Fatin Aliyah, BSc

CONTACT

[email protected]

+6581005851

Michelle Tseng, MD

SUB_INVESTIGATOR

Shing Fung Lee, MD

SUB_INVESTIGATOR

Syadwa Abdul Shukor, MD

SUB_INVESTIGATOR

Yiat Horng Leong, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 fractions HDR brachytherapy

Procedure

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 outcomes

  1. 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).

  2. 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).

  3. Progression-free survival (PFS)

    Time frame: 2 years from time of recruitment

    Percentage of patients who develop first evidence of cancer recurrence.

  4. Overall survival (OS)

    Time frame: 2 years from time of recruitment

    Percentage of patients who died from any cause

Secondary outcomes

  1. Long term toxicities

    Time frame: 2 years from time of recruitment

    To determine the long-term toxicities of this regimen based on CTCAE v5

Study contacts

Contact information is provided by the study sponsor or research team.

Fatin Aliyah, BSc

CONTACT

[email protected]

+6581005851

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Official study title

Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions: Dosimetric and Clinical Outcomes

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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