NCT04583254

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Cervical Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-02-04
• Primary completion: 2023-12-14
• Completion: 2028-12-14
• First posted: 2020-10-12
• Last updated: 2023-05-10

Locations

3 sites across 1 country: Canada