Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
2 other identifiers
interventional
48
1 country
3
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2021
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedStudy Start
First participant enrolled
February 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 14, 2028
ExpectedMay 10, 2023
May 1, 2023
2.9 years
October 2, 2020
May 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 years
Secondary Outcomes (1)
Tumour response based on imaging
3.5 years
Other Outcomes (11)
Quality of Life (QoL) - Bowel and urinary quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
8 years
Quality of Life (QoL) is measured by European Organization for Research and Treatment of Cancer (EORTC) and Core 30 (QLQ-C30) QoL questionnaires
8 years
Quality of Life (QoL) - acute vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
8 years
- +8 more other outcomes
Study Arms (2)
Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental
EXPERIMENTALArm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
ACTIVE COMPARATORInterventions
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
BC Cancer - Kelowna
Kelowna, British Columbia, V1Y 5L3, Canada
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, N6A 5W9, Canada
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lucas C Mendez, MD
London Health Sciences Centre, Lawson Health Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 2, 2020
First Posted
October 12, 2020
Study Start
February 4, 2021
Primary Completion
December 14, 2023
Study Completion (Estimated)
December 14, 2028
Last Updated
May 10, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share