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New treatment option for Cervical Cancer
Official title Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
ClinicalTrials.gov ID: NCT04583254
What this study is testing
What is Concurrent Chemotherapy?
Concurrent Chemotherapy is an investigational medicine, given as an once-weekly, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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
You likely can't join 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)
See the full eligibility 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:
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Kelowna, British Columbia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kelowna, British Columbia, Canada; London, Ontario, Canada; Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.