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NCT Number: NCT04583254

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

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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Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

BC Cancer - Kelowna, Kelowna, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental

Radiation

40 Gy / 15 Fractions EBRT + HDR-Brachytherapy

External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care

Radiation

45 Gy / 25 Fractions EBRT + HDR-Brachytherapy

Concurrent chemotherapy

Drug

Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

David D'Souza, MD

CONTACT

[email protected]

519-685-8650

Lucas C Mendez, MD

CONTACT

[email protected]

519-685-8650

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Academic Medical Organization of Southwestern Ontario

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2028
First posted
Oct 12, 2020
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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