beta
Trial Radar AI
Clinical Trial NCT06317389 (PACOME) for Cancer, Oncology, Oncoral Program is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
One study matched filter criteria
Card View
Back to Search

PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments 3,000 Observational Academic-Led

Recruiting
Clinical Trial NCT06317389 (PACOME) is an observational study for Cancer, Oncology, Oncoral Program that is recruiting. It started on 23 June 2025 with plans to enroll 3,000 participants. Led by Hospices Civils de Lyon, it is expected to complete by 1 July 2037. The latest data from ClinicalTrials.gov was last updated on 3 September 2025.
Brief Summary
With the shift to ambulatory care and the rise of ATCO oral anticancer drugs, a growing number of cancer patients are benefiting from oral treatment in an outpatient setting, which meets their needs and preference over injectable chemotherapy with more autonomy and less time spent in the hospital. However, outside the safe hospital context, the complex pharmacological profile of ATCO exposes patients to iatrogenic dr...Show More
Official Title

PACOME (PAtient Cancer Oral MEdication) Cohort of Patients Treated With Oral Anticancer Drugs Benefiting From Oncoral Multidisciplinary Monitoring in Real Life: Predictive Factors and Safety of Treatments

Conditions
CancerOncologyOncoral Program
Other Study IDs
  • PACOME
  • 69HCL23_1237
NCT ID Number
NCT06317389
Start Date (Actual)
2025-06-23
Last Update Posted
2025-09-03
Completion Date (Estimated)
2037-07
Enrollment (Estimated)
3,000
Study Type
Observational
Status
Recruiting
Keywords
Cancer outpatient
Oral anticancer drugs
Oncoral
Real-life
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Oncoral patients
All adult patients with cancer, treated with oral anticancer drugs and benefiting of the ONCORAL program at the Lyon-Sud hospital
Questionnaires
Patients will benefit of supervision by the ONCORAL team in the usual way and their intervention will be limited to completing questionnaires.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Relative-Dose-Intensity (RDI) in real life with a prospective follow-up of 6 months within the limit of the duration of treatment with oral anticancer drugs by setting up a data platform for adult patients taking oral anticancer drugs
Value of RDI (Relative-Dose-Intensity) is the ratio between the dose prescribed to the patient versus the maximum reference dose recommended by the product characteristics summary of the drug. This ratio is expressed as a percentage (%).
1, 3 and 6 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • aged over 18
  • eligible for treatment with oral anticancer drug (ATCO) (excluding clinical trial) in a cancer indication and whose treatment with an oral anticancer drug is scheduled
  • follow-up in one of the following departments at Lyon-Sud hospital: pulmonology, dermatology, hematology, medical oncology, gastroenterology or radiotherapy.
  • without a major psychiatric disorder likely to hinder the progress of the study, in the opinion of the investigator
  • participant in the ONCORAL monitoring program
  • Not having opposed participating in the study

  • in an institution
  • under legal protection measure
Hospices Civils de Lyon logoHospices Civils de Lyon
Study Central Contact
Contact: Catherine RIOUFOL, Pr, 04 78 86 43 68, [email protected]
Contact: Anne-Gaëlle CAFFIN, Dr, 04 78 86 38 26, [email protected]
1 Study Locations in 1 Countries
Groupement Hospitalier Sud - Unité de Pharmacie Clinique Oncologique, Pierre-Bénite, 69495, France
Catherine RIOUFOL, Pr, Contact
Florence RANCHON, MCU-PH, Sub-Investigator
Anne-Gaëlle CAFFIN, Dr, Sub-Investigator
Marie-Anne CERFON, PH, Sub-Investigator
Recruiting