Cervical CancerPhase 2NCT04583254
Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
A Phase 2 study testing External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental and Concurrent Chemotherapy in people with Cervical Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental and Concurrent Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 3 sitesCanada
- Study dates
- 4 Feb 2021to 14 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- Patients requiring paraaortic nodal irradiation
- Inflammatory bowel disease
- Connective tissue disorder (eg. scleroderma, systemic lupus erythematous)
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- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
BC Cancer - Kelowna
Kelowna, British Columbia, V1Y 5L3
Hamid Raziee, MD, hamid.raziee@bccancer.bc.ca
- Recruiting
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, N6A 5W9
Lucas C Mendez, MD, 519-685-8650, Lucas.Mendez@lhsc.on.ca
- Recruiting
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Eric Leung, MD, (416) 480-5000, eric.leung@sunnybrook.ca
About this study
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
- Being tested
- External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental, External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care, Concurrent Chemotherapy
- Keywords
- Hypofractionated External-beam Radiotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy ExperimentalRadiation
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of CareRadiation
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
Concurrent ChemotherapyDrug
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental | Experimental | Not described Receives: Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental; Drug: Concurrent Chemotherapy |
| Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care | Active comparator | Not described Receives: Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care; Drug: Concurrent Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the feasibility in the Canadian Health Care System
This trial aims to investigate its feasibility in the Canadian health care system. Feasibility will be defined as the ability to consent and randomize 48 patients over 3 years from date of site activation.
Measured: 3 years
Secondary outcomes (1)
Tumour response based on imaging
Tumour response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in the EMBRACE 2 protocol
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start4 Feb 2021
- Primary completion14 Dec 2023 (estimated)
- Study completion14 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Responsible party
- Principal investigator, Lucas Mendez, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Lucas C Mendez, MD, Principal investigator, London Health Sciences Centre, Lawson Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583254
- Sponsor's protocol ID
- HEROICC
- Other IDs
- ReDA ID#10482
- Status last verified
- May 2023
- First submitted
- 2 Oct 2020
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
- ClinicalTrials.gov ID
- NCT04583254
- Acronym / sponsor ID
- HEROICC
- Conditions
- Cervical Cancer
- Keywords
- Hypofractionated External-beam Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 14 Dec 2023 (estimated)
- Study completion
- 14 Dec 2028 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental | Experimental | Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental, Drug: Concurrent Chemotherapy |
| Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care | Active comparator | Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care, Drug: Concurrent Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- Histologically-confirmed invasive uterine cervical carcinoma of subtypes squamous cell, adenocarcinoma or adenosquamous cell
Key exclusion criteria (10 listed)
- 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
- Patients requiring paraaortic nodal irradiation
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental40 Gy / 15 Fractions EBRT + HDR-Brachytherapy | Radiation | Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental |
| External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care45 Gy / 25 Fractions EBRT + HDR-Brachytherapy | Radiation | Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care |
| Concurrent ChemotherapyWeekly cisplatin 40 mg/m2 for a maximum of 5 cycles | Drug | Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental, Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care |
Primary outcome
Investigate the feasibility in the Canadian Health Care System
Time frame: 3 years
This trial aims to investigate its feasibility in the Canadian health care system. Feasibility will be defined as the ability to consent and randomize 48 patients over 3 years from date of site activation.
1 secondary outcome
Tumour response based on imaging
Time frame: 3.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucas C Mendez, MD principal investigator
London Health Sciences Centre, Lawson Health Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental and Concurrent Chemotherapy in people with Cervical Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas C Mendez, MD (519-685-8650, Lucas.Mendez@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigate the feasibility in the Canadian Health Care System (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.