Evidence Development in Cancer Treatment - Real World: PREDiCTrw
ConditionCancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
QOL - quality of life
BehavioralQOL 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
Diagnostic testRadiographic or laboratory evaluation every 12 weeks +/- 2 weeks
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Overall survival
Overall survival from initiation of therapy
Time frame
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 monthsSecondary outcomes
1
Response rate
Response rate as defined by standard measurement for tumor site (eg RECIST 1.1)
Time frame
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months2
Progression/event free survival
Progression or event free survival from initiation of therapy
Time frame
From date of initiation until the date of progression or date of death from any cause, whichever came first, assessed up to 100 months3
Quality of life assessments
Quality of life assessments using EQ5D scale 1 to 5 with 5 being extreme problems
Time frame
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months4
Quality adjust survival
Quality adjusted survival from initiation of therapy
Time frame
From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov