search
Back to results

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

Primary Purpose

Cervical Cancer

Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
Concurrent Chemotherapy
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cervical Cancer focused on measuring Hypofractionated External-beam Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • BC Cancer - KelownaRecruiting
  • London Health Sciences Centre - London Regional Cancer ProgramRecruiting
  • Odette Cancer Centre - Sunnybrook Health Sciences CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental

Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 2, 2020
Last Updated
May 9, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Academic Medical Organization of Southwestern Ontario
search

1. Study Identification

Unique Protocol Identification Number
NCT04583254
Brief Title
Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
Official Title
Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
December 14, 2023 (Anticipated)
Study Completion Date
December 14, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Academic Medical Organization of Southwestern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer
Keywords
Hypofractionated External-beam Radiotherapy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental
Arm Type
Experimental
Arm Title
Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care
Arm Type
Active Comparator
Intervention Type
Radiation
Intervention Name(s)
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
Intervention Description
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
Intervention Type
Radiation
Intervention Name(s)
External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
Intervention Description
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
Intervention Type
Drug
Intervention Name(s)
Concurrent Chemotherapy
Intervention Description
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
Primary Outcome Measure Information:
Title
Investigate the feasibility in the Canadian Health Care System
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Tumour response based on imaging
Description
Tumour response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in the EMBRACE 2 protocol
Time Frame
3.5 years
Other Pre-specified Outcome Measures:
Title
Quality of Life (QoL) - Bowel and urinary quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
Description
QoL will be measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. EPIC was initially created for assessment of QoL in patients with prostate cancers. This questionnaire was used in the NRG RTOG 1203 protocol (NCT01672892) and comprehensively assesses bowel function and bother (bowel summary domain) and urinary function, bother, incontinence and irritation/obstruction (urinary domain). The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score.
Time Frame
8 years
Title
Quality of Life (QoL) is measured by European Organization for Research and Treatment of Cancer (EORTC) and Core 30 (QLQ-C30) QoL questionnaires
Description
Two European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaires (Core 30 (QLQ-C30). QLQ-C30 is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. The QLQ-C30 responses are regarding function and symptoms are on a scale of 1 (not at all) to 4 (very much). Also included are questions about overall health and quality of life. Responses are on a scale of 1 (very poor) to 7 (excellent).
Time Frame
8 years
Title
Quality of Life (QoL) - acute vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
Description
QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively. The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much).
Time Frame
8 years
Title
Quality of Life (QoL) - late vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
Description
QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively. The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much).
Time Frame
8 years
Title
Acute and late toxicity
Description
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (18). Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation. Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Time Frame
3 years and 3 months
Title
Assessment of cancer down staging throughout EBRT.
Description
To be assessed through volumetric comparison of gross tumor volume (GTV) and high risk clinical target volume (HR-CTV) contours in the pre-EBRT and brachytherapy MRI scans.
Time Frame
3 years
Title
Progression-free survival
Description
Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind.
Time Frame
8 years
Title
Locoregional progression-free survival
Description
Defined as time from date of randomization to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first.
Time Frame
8 years
Title
Metastasis-free survival
Description
Defined as time from date of randomization to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first.
Time Frame
8 years
Title
Cervical cancer-specific survival
Description
Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first.
Time Frame
8 years
Title
Overall survival
Description
Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first.
Time Frame
8 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas C Mendez, MD
Phone
519-685-8650
Email
Lucas.Mendez@lhsc.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
David D'Souza, MD
Phone
519-685-8650
Email
David.DSouza@lhsc.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucas C Mendez, MD
Organizational Affiliation
London Health Sciences Centre, Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Cancer - Kelowna
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamid Raziee, MD
Email
hamid.raziee@bccancer.bc.ca
Facility Name
London Health Sciences Centre - London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas C Mendez, MD
Phone
519-685-8650
Email
Lucas.Mendez@lhsc.on.ca
Facility Name
Odette Cancer Centre - Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Leung, MD
Phone
(416) 480-5000
Email
eric.leung@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs