Evidence Development in Cancer Treatment - Real World: PREDiCTrw

Cancer Clinical Trial

Official title:

Evidence Development in Cancer Treatment - Real World: PREDiCTrw

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06242912
• Other study ID #: PREDiCTrw
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: January 2029

Study information

• Verified date: January 2024
• Source: British Columbia Cancer Agency
• Contact: Cheryl Ho, MD
• Phone: 604 877 6000
• Email: cho[@]bccancer.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 2029
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects with cancer for which there remains ongoing questions regarding clinical effectiveness and/or cost effectiveness regarding a therapeutic agent

• 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.

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• QOL
QOL assessments using EQ5D +/- ESAS +/- CPC every 4-8 weeks +/- 2 weeks

Diagnostic Test:
• Radiographic or laboratory evaluation
Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks

Locations

Country	Name	City	State
Canada	BC Cancer	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
British Columbia Cancer Agency

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival from initiation of therapy	From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Response rate	Response rate as defined by standard measurement for tumor site (eg RECIST 1.1)	From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Progression/event free survival	Progression or event free survival from initiation of therapy	From date of initiation until the date of progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Quality of life assessments	Quality of life assessments using EQ5D	From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Quality adjust survival	Quality adjusted survival from initiation of therapy	From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Physician assessed response rate	Response rate as defined by physician assessed response	From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months