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

Who is this study for? Patients with intact cervical cancer
What treatments are being studied? External beam radiotherapy+Brachytherapy+Concurrent Chemotherapy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• International Federation of Gynecology and Obstetrics (FIGO) IA or IB1 cervical cancers if not surgical candidates, but amenable to definitive chemoradiotherapy as proposed in this trial.

• FIGO Stage IB2, IB3, IIA or IIB cervical cancers

• FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:

‣ largest node is less than 3 cm

⁃ less than 3 pathological nodes

⁃ No nodes located in the common iliac chain.

⁃ Cervical confined or with parametrial invasion

• Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell

• Candidate for definitive chemoradiotherapy to be delivered with weekly cisplatin

• Brachytherapy candidate

Locations
Other Locations
Canada
BC Cancer - Kelowna
RECRUITING
Kelowna
London Health Sciences Centre - London Regional Cancer Program
RECRUITING
London
Odette Cancer Centre - Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Lucas C Mendez, MD
Lucas.Mendez@lhsc.on.ca
519-685-8650
Backup
David D'Souza, MD
David.DSouza@lhsc.on.ca
519-685-8650
Time Frame
Start Date: 2021-02-04
Estimated Completion Date: 2028-12-14
Participants
Target number of participants: 48
Treatments
Experimental: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental
Active_comparator: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
Related Therapeutic Areas
Sponsors
Collaborators: Academic Medical Organization of Southwestern Ontario
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

This content was sourced from clinicaltrials.gov

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