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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
48
40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
BC Cancer - Kelowna
Kelowna, British Columbia, Canada
RECRUITINGLondon Health Sciences Centre - London Regional Cancer Program
London, Ontario, Canada
RECRUITINGOdette Cancer Centre - Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
RECRUITINGInvestigate the feasibility in the Canadian Health Care System
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.
Time frame: 3 years
Tumour response based on imaging
Tumour response rate on Magnetic resonance imaging (MRI) images will be graded as proposed in the EMBRACE 2 protocol
Time frame: 3.5 years
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