QOL - quality of lifeRadiographic or laboratory evaluation
QOL - quality of life: QOL assessments using EQ5D (Euroqol 5 dimension) +/- ESAS (Edmonton Symptom Assessment Scale) +/- CPC (Canadian Problem Checklist) every 4-8 weeks +/- 2 weeks
Radiographic or laboratory evaluation: Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks
Study summary
This pilot clinical trial aims to assess the real world quality of life and survival of patients treated with therapy that has preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or cost effectiveness in subjects with cancer. The goal of this study is to collect real world evidence with respect to quality of life and outcomes to support decision making.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Subjects with cancer for which there remains ongoing questions regarding clinical effectiveness and/or cost effectiveness regarding a therapeutic agent
* Eastern Co-operative Group (ECOG) 0-2
* Life expectancy of at least 12 weeks
* Adequate hematologic and end organ function for drug treatment per the clinician's assessment
* Asymptomatic or treated brain metastases permitted
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than 1% per year during the treatment period and for at least 5 months after the last dose.
* For men: agreement to remain abstinent (refrain from heterosexual intercourse with a female partner of childbearing potential or who is pregnant) or use contraceptive measures, and agreement to refrain from donating sperm, during the treatment period and for at least 5 months after the last dose.
* Ability to give informed consent for the study procedures defined in this protocol.
Exclusion Criteria:
* Treatment with any approved or investigational agent or participation in another clinical trial with therapeutic intent within 14 days prior to enrollment.
* Inability to complete quality of life questionnaires
* Pregnancy or breastfeeding.
* Any significant cardiovascular disease, comorbidity (i.e. recent major infection, HIV, tuberculosis) or major surgical procedure within 21 days that in the opinion of the investigator renders the proposed treatment unsafe.
* Subjects who are otherwise felt by the treating clinician to be unfit to proceed with this protocol.
Primary outcome measure(s)
Overall survival — From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months Overall survival from initiation of therapy
Trial sites (1)
Facility
City
Region
Status
BC Cancer
Vancouver
British Columbia
Recruiting
More British Columbia Cancer Agency trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.