Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284031
• Other study ID #: Brachy Study
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: National University Hospital, Singapore
• Contact: Fatin Aliyah, BSc
• Phone: +6581005851
• Email: fatin_hussin[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local control rate	Percentage of patients who recurred at the site of the initial primary (the cervix).	2 years from time of recruitment
Primary	Loco-regional control rate	Percentage of patients who recurred in the pelvis or regional lymph nodes (not in cervix).	2 years from time of recruitment
Primary	Progression-free survival (PFS)	Percentage of patients who develop first evidence of cancer recurrence.	2 years from time of recruitment
Primary	Overall survival (OS)	Percentage of patients who died from any cause	2 years from time of recruitment
Secondary	Long term toxicities	To determine the long-term toxicities of this regimen based on CTCAE v5	2 years from time of recruitment