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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
* Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
* Drug: Concurrent Chemotherapy


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental<br> | Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental<br>* 40 Gy / 15 Fractions EBRT + HDR-Brachytherapy<br>Drug: Concurrent Chemotherapy<br>* Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles<br>|
| Active Comparator: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care<br> | Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care<br>* 45 Gy / 25 Fractions EBRT + HDR-Brachytherapy<br>Drug: Concurrent Chemotherapy<br>* Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the feasibility in the Canadian Health Care System | This trial aims to investigate its feasibility in the Canadian health care system. Feasibility will be defined as the ability to consent and randomize 48 patients over 3 years from date of site activation. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response based on imaging | Tumour response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in the EMBRACE 2 protocol | 3.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypofractionated External-beam Radiotherapy