NCT06284031

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Jun 2023Dec 2026

Study Start

First participant enrolled

June 26, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2023

Completed
7 months until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 28, 2024

Status Verified

August 1, 2023

Enrollment Period

2.9 years

First QC Date

July 25, 2023

Last Update Submit

February 27, 2024

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Long term toxicities

    2 years from time of recruitment

Study Arms (1)

3 fractions

EXPERIMENTAL
Procedure: 3 fractions HDR brachytherapy

Interventions

3 fractions HDR brachytherapyPROCEDURE

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

3 fractions

Eligibility Criteria

Age21 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAs cervical cancer patients are females, we will only be recruiting female patients.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Post operative cervical cancer cases
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Vicky Koh, MD

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatin Aliyah, BSc

CONTACT

+6581005851fatin_hussin@nuhs.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2023

First Posted

February 28, 2024

Study Start

June 26, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 28, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)