Evidence Development in Cancer Treatment - Real World: PREDiCTrw

Launched by BRITISH COLUMBIA CANCER AGENCY · Feb 2, 2024

Keywords

ClinConnect Summary

The PREDiCTrw clinical trial is a research study focused on understanding the quality of life and survival outcomes for cancer patients receiving specific treatments that have shown some promise but still have unclear benefits or costs. The goal is to gather real-world information that can help doctors and patients make informed decisions about these therapies. If you are a cancer patient between the ages of 65 and 74, and your doctor believes you may benefit from a treatment that has uncertain effectiveness, you might be eligible to participate in this study.

To join the trial, you would need to be in reasonably good health, with a life expectancy of at least 12 weeks, and be able to complete quality of life questionnaires. You should not have recently participated in another study or received certain treatments. If you decide to participate, you will be asked to share your experiences and health status during the treatment, which will help researchers understand how these therapies affect patients in everyday life. This information could play a crucial role in improving cancer care for others in the future.

Gender

ALL

Eligibility criteria

• 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.