Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
Key facts
- Where
- Kelowna, London, and Toronto, CanadaSee the 3 sites
- Phase
- Phase 2
Where in Canada
- BC Cancer - KelownaKelowna, CanadaTaking people
- London Health Sciences Centre - London Regional Cancer ProgramLondon, CanadaTaking people
- Odette Cancer Centre, Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Trial code
- NCT04583254
- Record updated
- 10 May 2023
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Previous pelvic or abdominal radiotherapy; Patients requiring paraaortic nodal irradiation; Inflammatory bowel disease; Connective tissue disorder (eg. scleroderma, systemic lupus erythematous); 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; 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.