Shortened external beam radiotherapy for cervical cancer
Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
This study tests if a shorter course of radiation therapy combined with chemotherapy can effectively treat patients with locally advanced cervical cancer while being easier for them to manage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 3 sites (Kelowna, British Columbia and 2 other locations) |
| Trial ID | NCT04583254 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of a shortened external beam radiotherapy regimen combined with chemotherapy for patients with locally advanced cervical cancer. Participants will be randomized to receive either the experimental hypofractionated radiotherapy or the standard treatment regimen. The study aims to evaluate patient accrual in Canada and assess initial cancer response and treatment tolerability. The approach seeks to determine if a reduced number of radiation sessions can be effective and manageable for patients.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific stages of cervical cancer who are not surgical candidates but can undergo definitive chemoradiotherapy.
Not a fit: Patients with advanced stages of cervical cancer (FIGO stage IIIA, IIIB, IIIC2, IVA, or IVB) or those who have previously received pelvic or abdominal radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more efficient and tolerable treatment option for patients with cervical cancer.
How similar studies have performed: Other studies have explored hypofractionated radiotherapy approaches, showing promising results, but this specific regimen is being evaluated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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: 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 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
Where this trial is running
Kelowna, British Columbia and 2 other locations
- BC Cancer - Kelowna — Kelowna, British Columbia, Canada (Recruiting)
- London Health Sciences Centre - London Regional Cancer Program — London, Ontario, Canada (Recruiting)
- Odette Cancer Centre - Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Lucas C Mendez, MD — London Health Sciences Centre, Lawson Health Research Institute
- Study coordinator: Lucas C Mendez, MD
- Email: Lucas.Mendez@lhsc.on.ca
- Phone: 519-685-8650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.