RecruitingPhase 2NCT04583254

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


Sponsor

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

Enrollment

48 participants

Start Date

Feb 4, 2021

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a shorter, higher-dose radiation schedule (hypofractionated radiotherapy) combined with chemotherapy for women with cervical cancer who are treated with radiation rather than surgery. The goal is to see whether this condensed schedule is feasible and safe compared to the standard longer course. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with invasive cervical cancer (squamous cell, adenocarcinoma, or adenosquamous) - Your cancer is FIGO stage IB2, IB3, IIA, or IIB — or early-stage if surgery is not an option - Your doctor has determined you are a candidate for chemoradiation with weekly cisplatin and brachytherapy (internal radiation) **You may NOT be eligible if...** - Your cancer is stage IIIA, IIIB, IVA, or IVB (more advanced stages) - You have had prior pelvic or abdominal radiation - You have inflammatory bowel disease or a connective tissue disorder (e.g., lupus, scleroderma) - You have a rare cervical cancer subtype such as small cell, sarcoma, or melanoma - You cannot have an MRI scan - You cannot tolerate cisplatin chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

40 Gy / 15 Fractions EBRT + HDR-Brachytherapy

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

45 Gy / 25 Fractions EBRT + HDR-Brachytherapy

DRUGConcurrent Chemotherapy

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


Locations(3)

BC Cancer - Kelowna

Kelowna, British Columbia, Canada

London Health Sciences Centre - London Regional Cancer Program

London, Ontario, Canada

Odette Cancer Centre - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT04583254


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