NCT04583254RecruitingPhase 2
Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
Source: ClinicalTrials.gov · Last updated 10 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 2 Oct 2020
- Start date
- 4 Feb 2021
- Primary completion date
- 14 Dec 2023
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Diseases
- Cervical cancer
- NCT number
- NCT04583254
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 48
- From 4 Feb 2021 to the primary completion date, 14 Dec 2023
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic or abdominal radiotherapy
- Patients requiring paraaortic nodal irradiation
Other illness
- Inflammatory bowel disease
- Connective tissue disorder (eg. scleroderma, systemic lupus erythematous)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Cancer - Kelowna Coordinator of this site? Confirm its status | Kelowna | Canada | Recruiting |
| London Health Sciences Centre - London Regional Cancer Program Coordinator of this site? Confirm its status | London | Canada | Recruiting |
| Odette Cancer Centre, Sunnybrook Health Sciences Centre Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.