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Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study

NCT04583254 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-05-10

No results posted yet for this study

Summary

External radiation given in 25 fractions or so together with weekly chemotherapy and followed by 3 or 4 fractions of brachytherapy is the standard of care for patients with locally advanced cervical cancer.

This study investigates the role of shortened external radiotherapy regimen (hypofractionated radiotherapy) by randomizing patients to this experimental regimen versus the standard of care.The purpose of this study is to access the feasibility of patient accrual to this trial in the Canadian setting and to provide an initial evaluation of cancer response and treatment tolerability.

Conditions

Interventions

RADIATION

External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental

40 Gy / 15 Fractions EBRT + HDR-Brachytherapy

RADIATION

External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care

45 Gy / 25 Fractions EBRT + HDR-Brachytherapy

DRUG

Concurrent Chemotherapy

Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles

Sponsors & Collaborators

  • Academic Medical Organization of Southwestern Ontario

    collaborator OTHER

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Lucas C Mendez, MD · London Health Sciences Centre, Lawson Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-04
Primary Completion
2023-12-14
Completion
2028-12-14

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583254 on ClinicalTrials.gov