Health TrialsbyHealthPanel

PRecision Oncology Evidence Development in Cancer Treatment - Clinical: PREDiCTc

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 targeted therapy that has preliminary evidence of efficacy in subjects with advanced rare cancers or cancer harbouring rare molecular aberrations. The treatment has been granted conditional or full approved by Health Canada (HC) as effective and safe. Due to the rarity of the cancer or molecular aberration the uncertainty level of the health technology assessment (HTA) by the pan Canadian Oncology Review (pCODR) was too high for consideration of funding or it was not submitted for consideration. Consequently, the goal of this study is to generate real world evidence to support HTA decision making throughout the life cycle of the product.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject age greater than or equal to 18 years at the time of signature of informed consent.

Subjects with an incurable malignancy who have been identified to have a rare cancer or rare molecular aberration who is currently receiving Health Canada approved targeted therapy that is not nationally funded

ECOG 0-2

Life expectancy of at least 12 weeks

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

Subjects who are felt by the treating clinician to be unfit to proceed with this protocol.

Trial design

Design model

Single group

Treatments tested in this trial

  • QOL

    Behavioral

    QOL assessments using the ESAS, CPC, EQ5D every 4-8 weeks +/- 2 weeks

  • CT imaging

    Diagnostic test

    CT radiographic imaging every 12 weeks +/- 2 weeks

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Targeted therapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival from initiation of targeted therapy

Time frame
Baseline until death up to 5 years

Secondary outcomes

1

Response rate as defined by RECIST 1.1

Time frame
Baseline until progression up to 5 years
2

Response rate as defined by physician assessed response

Time frame
Baseline until progression up to 5 years
3

Progression free survival (PFS) from initiation of targeted therapy

Time frame
Baseline until progression up to 5 years
4

Quality of life (QoL) assessments using the EQ-5D every 8 weeks from initiation of targeted therapy

Time frame
Baseline until death up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

British Columbia Cancer Agency

Lead sponsor

Source ClinicalTrials.gov
Apply now