Prognostic Evaluation and Systematic Re-Assessment of Cholangiocarcinoma Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
Prospective observational cohort study including patients with a diagnosis of intrahepatic/perihilar cholangiocarcinoma at the central regional multidisciplinary conference, to assess therapy response, patient-reported quality of life, patient-reported symptoms/experiences and biomarkers. For patients diagnosed with localized unresectable disease, the study will document the multidisciplinary re-assessment of therapy response.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of intrahepatic- or perihilar cholangiocarcinoma at the regional multidisciplinary team conference
For inclusion in the re-assessment arm, a diagnosis of localized, unresectable cholangiocarcinoma at the regional multidisciplinary team conference and clinically evaluated as candidate for tumor-directed medical therapy
Disqualifiers
Age <18 years
Trial population
Swedish patients with newly diagnosed intrahepatic- or perihilar cholangiocarcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma
Change of initial treatment intention
Time frame
At first multidisciplinary re-assessment of therapy response after first-line oncological treatment (typically after 8 cycles, i.e. at an average of approximately 6 months)Secondary outcomes
1
Recurrence-free survival time
For patients undergoing curative intent surgery
Time frame
From date of surgery until the date of clinical-radiological recurrence or date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years2
Progression-free survival time
For patients with tumor-directed therapy. Assessment of progressive disease using Response Evaluation Criteria in Solid Tumor (RECIST criteria): Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease
Time frame
From therapy starting date until date of first documented progression (recurrence, progressive disease acc. to Response Evaluation Criteria in Solid Tumor) or date of death of any cause, assessed at study completion with est. average follow-up 2 years3
Overall survival time
Time frame
From date of diagnosis until the date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years4
Patient-reported quality of life according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
30 item questionnaire with 3 domains: symptoms, functional- and global health status. Items for symptoms and functioning are scored from 1-4 (symptoms - higher score represents higher level of symptomatology; function - higher score represents higher level of functioning). Items for global health status are scored from 1-7 (higher score represents a higher quality of life). Aggregated domain scores are calculated separately, and standardized to a range from 0 to 100, where a high score for symptoms represents a high level of symptomatology; while a high score for function and global health status represents a high level of functioning and a high quality of life.
Time frame
Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska University Hospital
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: