NCT04263948Completed
Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Plateform
Multidom Remote Monitoring of Patient With Advanced Pancreatic Cancer Treated With Florinox Using the PiCaDo Domomedecine Plateform
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
Pancreatic cancer is a rapidly developing cancer with a poor prognosis. The mFOLFIRINOX protocol has become the standard medical treatment for this pathology. However, mFOLFIRINOX is the cause of severe toxicities including leukoneutropenia, thrombocytopenia, diarrhea, nausea-vomiting, anorexia, asthenia, weight loss and peripheral sensory neuropathy. Therefore, its indication is limited to patients in good general condition. In practice, it is often interrupted upon the occurrence of hematological and/or clinical grade 3-4 toxicities, Remote patient tele-monitoring of symptoms (Patient Reported Outcomes), body weight, circadian rhythms, sleep and activity would allow the identification of early warning signals reflecting deterioration or improvement in the health of these fragile patients, and trigger proactive interventions, while they are outside the hospital. Thus, the MultiDom study proposes a comprehensive tele-monitoring and telecare strategy that would complement standard of care over a 7-weeks period to 42 consenting patients. The patients receive neoadjuvant or first line chemotherapy with mFOLFIRINOX for advanced or metastatic pancreatic cancer at one of four centres in Ile-de-France region (France).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 7 Feb 2020
- Start date
- 1 Jun 2021
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Diseases
- Pancreatic cancer
- NCT number
- NCT04263948
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From 1 Jun 2021 to the primary completion date, 30 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior administration of chemotherapy or radiotherapy
- Biological anomalies contraindicating the administration of one or more drugs which make up FOLFIRINOX
Other illness
- Immediately resectable pancreatic cancer
- Uncontrolled venous or arterial thrombosis
Age
- Age \<18 and\> 85 years old
Other
- No histological or cytological evidence of pancreatic adenocarcinoma
- Performance status\> 1 (WHO)
- Skin jaundice and / or pruritus
- Co morbidity not controlled by a specific treatment
- Lack of GPRS coverage in the home
- Patient participating in another clinical study
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- Pregnant, lactating or parturient woman
- Patient hospitalized without consent.
Who the study is looking for
- -Histological or cytological diagnosis of pancreatic adenocarcinoma
- Locally advanced or metastatic pancreatic cancer
- With or without previous surgery (pancreas and / or metastases)
- Performance status of 0 or 1 according to WHO
- Age between 18 and 85 years old included
- No history of prior chemotherapy or radiotherapy
- Absence of cutaneous or mucosal jaundice or skin pruritus
- No proven thrombosis
- Absence of heart disease or other pathology poorly controlled by current treatments
- Bilirubinemia and alkaline phosphatases \<1.5 ULN (with or without stent)
- Hematological, renal and hepatic laboratory tests authorizing the administration of mFOLFIRINOX
- Affiliated subject or beneficiary of a social security scheme
- Patient who freely signed informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinique du Mousseau Coordinator of this site? Confirm its status | Évry | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.