A Phase 2 interventional study of External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental and External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care in Cervical Cancer, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 3 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 2, Interventional, and Screening
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 48 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 309 studies on the registry; 126 are open to participants now.
Counted across the registry records on this site, refreshed daily.
FIGO stage IIIC1 cervical cancers are candidates but must meet all the following criteria:
Exclusion Criteria:
Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental · Drug: Concurrent Chemotherapy
Radiation: External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care · Drug: Concurrent Chemotherapy
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
Investigate 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
Quality of Life (QoL) - Bowel and urinary quality of life as measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.
QoL will be measured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. EPIC was initially created for assessment of QoL in patients with prostate cancers. This questionnaire was used in the NRG RTOG 1203 protocol (NCT01672892) and comprehensively assesses bowel function and bother (bowel summary domain) and urinary function, bother, incontinence and irritation/obstruction (urinary domain). The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score.
Time frame: 8 years
Quality of Life (QoL) is measured by European Organization for Research and Treatment of Cancer (EORTC) and Core 30 (QLQ-C30) QoL questionnaires
Two European Organization for Research and Treatment of Cancer (EORTC) QoL questionnaires (Core 30 (QLQ-C30). QLQ-C30 is used for all cancers and has several symptom scales, five functional scales (physical, emotional, social, role, cognitive) and a global health status scale. The QLQ-C30 responses are regarding function and symptoms are on a scale of 1 (not at all) to 4 (very much). Also included are questions about overall health and quality of life. Responses are on a scale of 1 (very poor) to 7 (excellent).
Time frame: 8 years
Quality of Life (QoL) - acute vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively. The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much).
Time frame: 8 years
Quality of Life (QoL) - late vaginal and sexual symptoms as measured by the cervical cancer module (QLQ-CX24)
QoL will be measured by the cervical cancer module (QLQ-CX24). QLQ-CX24 includes cancer - and treatment - related items and symptoms regarding sexuality. Acute and late vaginal and sexual QoL will be assessed using the QLQ-CX24 vaginal and sexual domains respectively. The QLQ-CX24 responses are regarding function and symptoms of sexual and vagina health. It is based on a scale of 1 (not at all) to 4 (very much).
Time frame: 8 years
Acute and late toxicity
This outcome is assessed by physicians during each follow-up appointment, and scored according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (18). Clinically relevant toxicities of gastrointestinal, genitourinary, vaginal and non-specific general symptoms (i.e. fatigue, malaise and pain) will be collected. Hematological disorders will also be collected through weekly blood work checks. Acute toxicities will be collected at baseline, and then weekly during radiotherapy/chemoradiotherapy and at 3 months after completion of radiation. Late toxicities will be collected from 3 months after completion of radiation onwards until the end of follow-up.
Time frame: 3 years and 3 months
Assessment of cancer down staging throughout EBRT.
To be assessed through volumetric comparison of gross tumor volume (GTV) and high risk clinical target volume (HR-CTV) contours in the pre-EBRT and brachytherapy MRI scans.
Time frame: 3 years
Progression-free survival
Defined as time from date of randomization to date of progression, date of death from any cause, or date of last follow-up, whichever occurs first. Cancer progression can be identified during physical exam, biopsy, or imaging of any kind.
Time frame: 8 years
Locoregional progression-free survival
Defined as time from date of randomization to date of locoregional progression, date of death from any cause, or date of last follow-up, whichever occurs first.
Time frame: 8 years
Metastasis-free survival
Defined as time from date of randomization to date of development of metastasis, date of death from any cause, or date of last follow-up, whichever occurs first.
Time frame: 8 years
Cervical cancer-specific survival
Defined as time from date of randomization to date of death attributed to cervical cancer, or date of last-follow-up, whichever occurs first.
Time frame: 8 years
Overall survival
Defined as time from date of randomization to date of death from any cause, or date of last follow-up, whichever occurs first.
Time frame: 8 years
Plan to share: No
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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's