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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
Must not have
FIGO stage IIIC1 with node greater than 3 cm, common iliac node or greater than 2 pathological nodes
Previous pelvic or abdominal radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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I am eligible for a specific cancer treatment involving chemotherapy and radiation with cisplatin.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer is at a specific stage and has spread to certain lymph nodes.
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I have had radiotherapy in my pelvic or abdominal area before.
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I need radiation therapy for lymph nodes near my aorta.
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I am mostly bedridden due to my health condition.
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I cannot receive cisplatin treatment.
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I have inflammatory bowel disease.
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My cancer is in an advanced stage, but not the earliest or final stages.
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I have a connective tissue disorder like scleroderma or lupus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Investigate the feasibility in the Canadian Health Care System
Secondary study objectives
Tumour response based on imaging
Other study objectives
Acute Coryza
Malignant Neoplasms
Cervical cancer-specific survival
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
680 Previous Clinical Trials
421,885 Total Patients Enrolled
Academic Medical Organization of Southwestern OntarioOTHER
15 Previous Clinical Trials
1,385 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

Concurrent Chemotherapy Clinical Trial Eligibility Overview. Trial Name: NCT04583254 — Phase 2
Cervical Cancer Research Study Groups: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental, Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
Cervical Cancer Clinical Trial 2023: Concurrent Chemotherapy Highlights & Side Effects. Trial Name: NCT04583254 — Phase 2
Concurrent Chemotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04583254 — Phase 2
~10 spots leftby Nov 2025
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