Recruiting
Phase 2

Hypofractionated Radiotherapy

Sponsor:

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

Code:

NCT04583254

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Concurrent Chemotherapy

Study Details

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.

Conditions

Cervical Cancer

Study ID

NCT04583254

Start date

Feb 4, 2021

Status verified date

May, 2023

Completion date

Dec 14, 2028

Anticipated

Primary completion date

Dec 14, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Arm 1 EBRT+High-dose (HDR) Brachytherapy Experimental

active comparator: Arm 2 EBRT+High-dose (HDR) Brachytherapy Standard of Care

Interventions

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

40 Gy / 15 Fractions EBRT + HDR-Brachytherapy

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

45 Gy / 25 Fractions EBRT + HDR-Brachytherapy

Concurrent Chemotherapy

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

Primary outcome measure

  • Investigate the feasibility in the Canadian Health Care System [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Lucas C Mendez, MD

519-685-8650Lucas.Mendez@lhsc.on.ca

David D'Souza, MD

519-685-8650David.DSouza@lhsc.on.ca

Locations

BC Cancer - Kelowna

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Hamid Raziee, MD

hamid.raziee@bccancer.bc.ca

London Health Sciences Centre - London Regional Cancer Program

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Lucas C Mendez, MD

519-685-8650Lucas.Mendez@lhsc.on.ca

Odette Cancer Centre - Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Eric Leung, MD

(416) 480-5000eric.leung@sunnybrook.ca

More Information

Sponsor

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

Last update posted

May 10, 2023

Last verified

May, 2023

Keywords

  • Hypofractionated External-beam Radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2023-05-10.