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

Phase 2

Recruiting

• Conditions: Cervical Cancer
• Interventions: 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

• Registration Number: NCT04583254
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-12
• Study Start: 2021-02-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Primary Completion: 2023-12-14
• Study Completion: 2028-12-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental	External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental	-
Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental	Concurrent Chemotherapy	-
Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care	External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care	-
Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care	Concurrent Chemotherapy	-

Primary Outcome Measures

Name	Time	Method
Investigate the feasibility in the Canadian Health Care System	3 years	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.

Secondary Outcome Measures

Name	Time	Method
Tumour response based on imaging	3.5 years	Tumour response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in the EMBRACE 2 protocol

Trial Locations

Locations (3)

Odette Cancer Centre - Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

BC Cancer - Kelowna; 🇨🇦 Kelowna, British Columbia, Canada

London Health Sciences Centre - London Regional Cancer Program; 🇨🇦 London, Ontario, Canada