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Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study

RECRUITINGPhase 2Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Actively Recruiting
PhasePhase 2
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Started2021-02-04
Est. completion2023-12-14
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04583254

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerCervical Cancer

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