Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
NCT ID: NCT04583254
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
48 participants
INTERVENTIONAL
2021-02-04
2028-12-14
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
Interventions
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External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
Eligibility Criteria
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Inclusion Criteria
* 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:
1. largest node is less than 3 cm
2. less than 3 pathological nodes
3. No nodes located in the common iliac chain.
4. 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 Criteria
* 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)
* 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
18 Years
FEMALE
No
Sponsors
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Academic Medical Organization of Southwestern Ontario
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Lucas Mendez
Principal Investigator
Principal Investigators
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Lucas C Mendez, MD
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre, Lawson Health Research Institute
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ReDA ID#10482
Identifier Type: OTHER
Identifier Source: secondary_id
HEROICC
Identifier Type: -
Identifier Source: org_study_id
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