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

Cervical Cancer

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.

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Participation Requirements

  • Sex:

    FEMALE

  • Eligible Ages:

    18 and up

Participation 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

Study Location

BC Cancer - Kelowna
BC Cancer - Kelowna
Kelowna, British Columbia
Canada

Contact Study Team

Primary Contact

Hamid Raziee, MD

[email protected]
London Health Sciences Centre - London Regional Cancer Program
London Health Sciences Centre - London Regional Cancer Program
London, Ontario
Canada

Contact Study Team

Primary Contact

Lucas C Mendez, MD

[email protected]
519-685-8650
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Odette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Eric Leung, MD

[email protected]
(416) 480-5000
Study Sponsored By
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
Participants Required
More Information
Study ID: NCT04583254