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Hypofractionated Radiotherapy for Cervical Cancer
Phase 2
Recruiting
Led By Lucas C Mendez, MD
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or older
Brachytherapy candidate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
Study Summary
This trial is testing a shorter external radiation regimen for patients with locally advanced cervical cancer to see if it is feasible and tolerable.
Who is the study for?
This trial is for adults with certain stages of cervical cancer (up to FIGO stage IIB) who haven't had previous pelvic/abdominal radiotherapy or require paraaortic nodal irradiation. They must be able to undergo an MR scan, have a performance status of 3 or less, and be candidates for chemotherapy with cisplatin.Check my eligibility
What is being tested?
The HEROICC-Trial compares standard external beam radiotherapy plus chemotherapy followed by brachytherapy against a shortened (hypofractionated) radiotherapy regimen. The goal is to see if the experimental approach works well in Canada and how patients respond to it.See study design
What are the potential side effects?
Potential side effects include skin irritation, fatigue, gastrointestinal issues like nausea and diarrhea from both radiation and chemotherapy. There may also be risks associated with brachytherapy such as localized pain or discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am a candidate for brachytherapy.
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My cervical cancer is at an early to mid-stage.
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My cervical cancer is limited to the cervix or has spread to nearby tissues.
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My cervical cancer is at stage IIIC1.
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My cervical cancer is confirmed and is one of the specified types.
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I have fewer than 3 cancerous lymph nodes.
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My largest lymph node is smaller than 3 cm.
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My cancer has not spread to the common iliac lymph nodes.
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My cervical cancer is in early stages (IA or IB1) and I can't have surgery, but can undergo chemoradiotherapy.
Select...
I am eligible for a specific cancer treatment involving chemotherapy and radiation with cisplatin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Investigate the feasibility in the Canadian Health Care System
Secondary outcome measures
Tumour response based on imaging
Other outcome measures
Acute Coryza
Malignant Neoplasms
Cervical cancer-specific survival
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 EBRT+High-dose (HDR) Brachytherapy ExperimentalExperimental Treatment2 Interventions
Group II: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of CareActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Concurrent Chemotherapy
2001
Completed Phase 3
~330
Find a Location
Who is running the clinical trial?
Lawson Health Research InstituteLead Sponsor
661 Previous Clinical Trials
413,874 Total Patients Enrolled
Academic Medical Organization of Southwestern OntarioOTHER
13 Previous Clinical Trials
1,255 Total Patients Enrolled
Lucas C Mendez, MDPrincipal InvestigatorLondon Health Sciences Centre, Lawson Health Research Institute
1 Previous Clinical Trials
58 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My cancer is at a specific stage and has spread to certain lymph nodes.I have had radiotherapy in my pelvic or abdominal area before.I need radiation therapy for lymph nodes near my aorta.I am mostly bedridden due to my health condition.I cannot receive cisplatin treatment.My cancer is not one of the listed types (like melanoma or small cell).I have inflammatory bowel disease.My cervical cancer is at an early to mid-stage.I am a candidate for brachytherapy.My cervical cancer is limited to the cervix or has spread to nearby tissues.My cervical cancer is at stage IIIC1.My cervical cancer is confirmed and is one of the specified types.My cancer is in an advanced stage, but not the earliest or final stages.I have fewer than 3 cancerous lymph nodes.My largest lymph node is smaller than 3 cm.My cancer has not spread to the common iliac lymph nodes.My cervical cancer is in early stages (IA or IB1) and I can't have surgery, but can undergo chemoradiotherapy.I have a connective tissue disorder like scleroderma or lupus.I am eligible for a specific cancer treatment involving chemotherapy and radiation with cisplatin.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental
- Group 2: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the dangers associated with Concurrent Chemotherapy?
"Because a Phase 2 trial only provides some evidence of safety and none for efficacy, our team at Power estimated that Concurrent Chemotherapy would be safe on a scale of 1 to 3."
Answered by AI
Are there any vacancies in this trial for new participants?
"The latest information from clinicaltrials.gov suggests that this trial is still looking for participants. The study was first advertised on February 4th, 2021 and received its most recent update April 12th, 2022."
Answered by AI
In how many places is this research being done?
"Currently, there are 4 locations running this clinical trial: BC Cancer - Kelowna in Kelowna, Odette Cancer Centre - Sunnybrook Health Sciences Centre in Toronto, London Health Sciences Centre - London Regional Cancer Program in London. There are also 4 other potential sites."
Answered by AI
How many people are signups for this clinical trial?
"Yes, the information on clinicaltrials.gov says that this clinical trial is currently looking for patients. The study was initially posted on 2/4/2021 and was most recently edited on 4/12/2022. The clinical trial is looking for 48 participants across 4 sites"
Answered by AI
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