Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT04583254

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

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2023-05-10

48

Participants Needed

3

Research Sites

410 weeks

Total Duration

On this page

Sponsors

L

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

Lead Sponsor

A

Academic Medical Organization of Southwestern Ontario

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • FIGO stage IA or IB1 cervical cancer if not surgical candidates but suitable for chemoradiotherapy
  • FIGO stage IB2, IB3, IIA, or IIB cervical cancers
  • FIGO stage IIIC1 cervical cancers with largest node less than 3 cm, fewer than 3 pathological nodes, no common iliac chain nodes, and cervical confined or with parametrial invasion
  • Histologically confirmed invasive uterine cervical carcinoma of squamous cell, adenocarcinoma, or adenosquamous cell subtypes
  • Candidate for definitive chemoradiotherapy with weekly cisplatin
  • Candidate for brachytherapy
Not Eligible

You will not qualify if you...

  • FIGO stage IIIA, IIIB, IIIC2, IVA, or IVB
  • FIGO stage IIIC1 with node greater than 3 cm, common iliac node involvement, or more than 2 pathological nodes
  • Previous pelvic or abdominal radiotherapy
  • Need for paraaortic nodal irradiation
  • Inflammatory bowel disease
  • Connective tissue disorders such as scleroderma or systemic lupus erythematous
  • Histologies including neuroendocrine, glassy cell, small cell, adenoid cystic, adenoid basal, clear cell, serous, endometrioid, verrucous carcinoma, melanoma, or sarcoma
  • Unable to undergo MR scan
  • ECOG performance status greater than 3
  • Not a candidate for cisplatin chemotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

BC Cancer - Kelowna

Kelowna, British Columbia, Canada, V1Y 5L3

Actively Recruiting

2

London Health Sciences Centre - London Regional Cancer Program

London, Ontario, Canada, N6A 5W9

Actively Recruiting

3

Odette Cancer Centre - Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

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Research Team

L

Lucas C Mendez, MD

CONTACT

D

David D'Souza, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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