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Trial Title:
Evidence Development in Cancer Treatment - Real World: PREDiCTrw
NCT ID:
NCT06242912
Condition:
Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
QOL - quality of life
Description:
QOL assessments using EQ5D (Euroqol 5 dimension) +/- ESAS (Edmonton Symptom Assessment
Scale) +/- CPC (Canadian Problem Checklist) every 4-8 weeks +/- 2 weeks
Arm group label:
Therapy
Intervention type:
Diagnostic Test
Intervention name:
Radiographic or laboratory evaluation
Description:
Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks
Arm group label:
Therapy
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.
Detailed description:
Clinical practice involves incorporating new data into treatment recommendations
including non randomized phase I/II studies. Clinicians' decision-making is swayed by
alternative endpoints like response rate (RR), depth of response and progression free
survival (PFS), presumed to be surrogates for overall survival (OS). Determination of the
added value of these new therapies in terms of outcomes and quality of life (QOL) is
challenging in the absence of comparators in trials resulting in increased uncertainty in
terms of outcomes, quality of life and cost-effectiveness.
With the possibility of a randomized clinical trial evidence being low in certain
populations, the use of real world data (RWD) can provide information regarding therapies
with preliminary evidence of efficacy but uncertainty of the magnitude of clinical
benefit or cost effectiveness. With RWD, patients may receive access to therapies and
participate in the evidence generation package.
This study proposes to use RWD to generate evidence to evaluate therapies with
preliminary evidence of efficacy but uncertainty of the magnitude of clinical benefit or
cost effectiveness. The key components include regular interval disease assessments (eg
radiographic imaging) and collection of patient reported outcomes (PROs) using
standardized QOL questionnaires. The aim is to provide high quality real world evidence
(RWE) for assessment and economic modelling to reduce uncertainty and facilitate
decision-making.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
BC Cancer
Address:
City:
Vancouver
Zip:
V5Z4E6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Fatima Usman
Phone:
604 877 6000
Email:
fatima.usman1@bccancer.bc.ca
Start date:
January 22, 2024
Completion date:
January 2029
Lead sponsor:
Agency:
British Columbia Cancer Agency
Agency class:
Other
Source:
British Columbia Cancer Agency
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06242912
