Cervical Cancer Brachytherapy With Interstitial Needles in 3 Fractions

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

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Procedure: 3 fractions HDR brachytherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fatin Aliyah, BSc; Phone Number: +6581005851; Email: fatin_hussin@nuhs.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore, 119074
    • Recruiting
    • National University Hospital
    • Contact: Fatin Aliyah, BSc; Phone Number: +6581005851; Email: fatin_hussin@nuhs.edu.sg
    • Sub-Investigator: Syadwa Abdul Shukor, MD
    • Sub-Investigator: Yiat Horng Leong, MD
    • Sub-Investigator: Shing Fung Lee, MD
    • Sub-Investigator: Michelle Tseng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3 fractions	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control rate	Percentage of patients who recurred at the site of the initial primary (the cervix).	2 years from time of recruitment
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
Progression-free survival (PFS)	Percentage of patients who develop first evidence of cancer recurrence.	2 years from time of recruitment
Overall survival (OS)	Percentage of patients who died from any cause	2 years from time of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long term toxicities	To determine the long-term toxicities of this regimen based on CTCAE v5	2 years from time of recruitment

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Investigators: Principal Investigator: Vicky Koh, MD, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms
• Other Study ID Numbers: Brachy Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No