Testing External beam radiotherapy (EBRT) + for cervical cancer
Official title: Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
- Phase 2
- 2 groups
- Sites in Kelowna, London and 1 more city
- Recruiting
Interventions
- Radiation therapy
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
- Radiation therapy
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
- Medication
Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
BC Cancer - Kelowna
Kelowna, British Columbia
- Recruiting
London Health Sciences Centre - London Regional Cancer Program
London, Ontario
- Recruiting
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
Exclusion
- −FIGO stage IIIA, IIIB, IIIC2, IVA or IVB
- −FIGO stage IIIC1 with node greater than 3 cm, common iliac node or greater than 2 pathological nodes
- −Previous pelvic or abdominal radiotherapy
- −Inflammatory bowel disease
- −Connective tissue disorder (eg. scleroderma, systemic lupus erythematous)
- −Neuroendocrine, glassy cell, small cell, adenoid cystic carcinoma, adenoid basal carcinoma, clear cell, serous, endometrioid, verrucous carcinoma, melanoma, and sarcoma histologies
- −Patient unable to undergo MR scan
- −Eastern Cooperative Oncology Group (ECOG) performance status greater than 3
- −Not a cisplatin candidate
- −Patients requiring paraaortic nodal irradiation
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to detect a condition before symptoms appear.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives one or more of: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental and Concurrent Chemotherapy.
Registry label: A: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental
Group B, the comparison group, receives one or more of: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of CareStandard of careThe treatment normally given for a condition outside a study.Read more → and Concurrent Chemotherapy.
Registry label: B: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 48 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Investigate the feasibility in the Canadian Health Care System — measured over 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04583254 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy ExperimentalRadiation
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of CareRadiation
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Concurrent ChemotherapyDrug
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 3 years.
The study as a whole is currently expected to finish around 2028-12-14.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 48 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Kelowna, British Columbia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.