NCT06242912

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
32mo left

Started Jan 2024

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Jan 2029

First Submitted

Initial submission to the registry

January 22, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

January 22, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3.9 years

First QC Date

January 22, 2024

Last Update Submit

September 22, 2025

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Response rate

    From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months

  • Progression/event free survival

    From date of initiation until the date of progression or date of death from any cause, whichever came first, assessed up to 100 months

  • Quality of life assessments

    From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months

  • Quality adjust survival

    From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months

  • Physician assessed response rate

    From date of initiation until the date of death from any cause, whichever came first, assessed up to 100 months

Study Arms (1)

Therapy

EXPERIMENTAL

Regular disease assessment (eg radiographic imaging) and quality of life (QOL) questionnaires

Behavioral: QOL - quality of lifeDiagnostic Test: Radiographic or laboratory evaluation

Interventions

QOL - quality of lifeBEHAVIORAL

QOL assessments using EQ5D (Euroqol 5 dimension) +/- ESAS (Edmonton Symptom Assessment Scale) +/- CPC (Canadian Problem Checklist) every 4-8 weeks +/- 2 weeks

Therapy
Radiographic or laboratory evaluationDIAGNOSTIC_TEST

Radiographic or laboratory evaluation every 12 weeks +/- 2 weeks

Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z4E6, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Cheryl Ho, MD

    BC Cancer

    STUDY CHAIR

Central Study Contacts

Cheryl Ho, MD

CONTACT

604 877 6000cho@bccancer.bc.ca

Howard Lim, MD

CONTACT

604 877 6000hlim@bccancer.bc.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

February 5, 2024

Study Start

January 22, 2024

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)