Clinical trial NCT04583254: 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
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: Hypofractionated External-beam Radiotherapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2020-10-12
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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:

  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

Primary outcomes:
measure: Investigate the feasibility in the Canadian Health Care System
timeFrame: 3 years
Secondary outcomes:
measure: Tumour response based on imaging
timeFrame: 3.5 years
Other outcomes:
measure: Quality of Life (QoL) - Bowel and urinary quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
timeFrame: 8 years
measure: Quality of Life (QoL) is measured by European Organization for Research and Treatment of Cancer (EORTC) and Core 30 (QLQ-C30) QoL questionnaires
timeFrame: 8 years
measure: Quality of Life (QoL) - acute vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
timeFrame: 8 years
measure: Quality of Life (QoL) - late vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
timeFrame: 8 years
measure: Acute and late toxicity
timeFrame: 3 years and 3 months
measure: Assessment of cancer down staging throughout EBRT.
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 8 years
measure: Locoregional progression-free survival
timeFrame: 8 years
measure: Metastasis-free survival
timeFrame: 8 years
measure: Cervical cancer-specific survival
timeFrame: 8 years
measure: Overall survival
timeFrame: 8 years
Locations:
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre - Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre, Lawson Health Research Institute
name: Lucas C Mendez, MD
role: PRINCIPAL_INVESTIGATOR
References: