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Recruiting NCT04583254

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

Phase II Interventional Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental, External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care, Concurrent Chemotherapy.
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Radiation External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental
    40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
  • 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

  • Investigate the feasibility in the Canadian Health Care System [Time frame: 3 years]
Secondary outcome measures (1)
  • Tumour response based on imaging [Time frame: 3.5 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Screening

Study locations

Canada · 3 centers
  • BC Cancer - Kelowna — Kelowna
  • London Health Sciences Centre - London Regional Cancer Program — London
  • Odette Cancer Centre - Sunnybrook Health Sciences Centre — Toronto

Identifiers

NCT: NCT04583254 · HEROICC · ReDA ID#10482

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗