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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04583254
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
Academic Medical Organization of Southwestern Ontario
Information provided by (Responsible Party):
Lucas Mendez, 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.


Condition or disease Intervention/treatment Phase
Cervical Cancer 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 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Hypofractionated External-beam RadiOtherapy for Intact Cervical Cancer (HEROICC-Trial): A Feasibility Study
Actual Study Start Date : February 4, 2021
Estimated Primary Completion Date : December 14, 2023
Estimated Study Completion Date : December 14, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Experimental: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy

Drug: Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles

Active Comparator: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy

Drug: Concurrent Chemotherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles




Primary Outcome Measures :
  1. Investigate the feasibility in the Canadian Health Care System [ Time Frame: 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 :
  1. Tumour response based on imaging [ Time Frame: 3.5 years ]
    Tumour response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in the EMBRACE 2 protocol


Other Outcome Measures:
  1. Quality of Life (QoL) - Bowel and urinary quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. [ Time Frame: 8 years ]

    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.


  2. Quality of Life (QoL) is measured by European Organization for Research and Treatment of Cancer (EORTC) and Core 30 (QLQ-C30) QoL questionnaires [ Time Frame: 8 years ]

    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).


  3. Quality of Life (QoL) - acute vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24) [ Time Frame: 8 years ]

    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).


  4. Quality of Life (QoL) - late vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24) [ Time Frame: 8 years ]

    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).


  5. Acute and late toxicity [ Time Frame: 3 years and 3 months ]
    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.

  6. Assessment of cancer down staging throughout EBRT. [ Time Frame: 3 years ]
    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.

  7. Progression-free survival [ Time Frame: 8 years ]
    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.

  8. Locoregional progression-free survival [ Time Frame: 8 years ]
    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.

  9. Metastasis-free survival [ Time Frame: 8 years ]
    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.

  10. Cervical cancer-specific survival [ Time Frame: 8 years ]
    Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first.

  11. Overall survival [ Time Frame: 8 years ]
    Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583254


Contacts
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Contact: Lucas C Mendez, MD 519-685-8650 Lucas.Mendez@lhsc.on.ca
Contact: David D'Souza, MD 519-685-8650 David.DSouza@lhsc.on.ca

Locations
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Canada, British Columbia
BC Cancer - Kelowna Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Hamid Raziee, MD       hamid.raziee@bccancer.bc.ca   
Canada, Ontario
London Health Sciences Centre - London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Lucas C Mendez, MD    519-685-8650    Lucas.Mendez@lhsc.on.ca   
Odette Cancer Centre - Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Eric Leung, MD    (416) 480-5000    eric.leung@sunnybrook.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Academic Medical Organization of Southwestern Ontario
Investigators
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Principal Investigator: Lucas C Mendez, MD London Health Sciences Centre, Lawson Health Research Institute
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Responsible Party: Lucas Mendez, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT04583254    
Other Study ID Numbers: HEROICC
ReDA ID#10482 ( Other Identifier: Lawson Health Research Institute )
First Posted: October 12, 2020    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lucas Mendez, Lawson Health Research Institute:
Hypofractionated External-beam Radiotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases