Status:
COMPLETED
Prospective Evaluation of a Program for Early Identification of Needs and Multidisciplinary Intervention in Supportive Care in Digestive Oncology
Lead Sponsor:
Institut Curie
Conditions:
Non-colorectal Cancer (Esophagus, Stomach, Liver/Bile Ducts, Pancreas, Neuroendocrine Carcinoma)
Colorectal With Associated Risk Factors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with advanced gastrointestinal (GI) cancers are very often sarcopenic/malnourished at diagnosis (\> 60% of cases) and at high risk of rapid clinical deterioration. These patients have importa...
Detailed Description
All patients will receive usual care including: * Chemotherapy at the investigator's choice, * Outpatient clinical visits according to the regular schedule, * Tumor evaluation based on tumor marker s...
Eligibility Criteria
Inclusion
- Signed and dated informed consent,
- Age ≥ 18 years (no superior limit),
- Histologically confirmed (1) non-colorectal cancer (esophagus, stomach, liver/bile ducts, pancreas, neuroendocrine carcinoma) or (2) colorectal with associated risk factors i.e. ECOG PS 2 (defining significant limitation in daily activities), and/or weight loss ≥ 5% in 1 month or ≥ 10% in 6 months (defining malnutrition/HAS 2019),
- Advanced disease not amenable to surgery, radiation, or combined modality therapy with curative intent (previous resection of primary tumor allowed), treated with first-line chemotherapy for advanced disease (previous \[neo\]adjuvant chemo\[radio\]therapy allowed); or resectable/potentially resectable disease receiving a triplet chemotherapy regimen in a peri-operative setting (e.g. FOLFIRINOX, FLOT) (moderate risk at frailty score)
- Patients able to attend for administration of chemotherapy,
- Life expectancy ≥ 3 months,
- Registration in a National Health Care System (Couverture Maladie Universelle \[CMU\] included).
Exclusion
- Other active non gastro-intestinal cancers
- Any medical (including psychiatric, musculoskeletal, or neurological) condition contra-indicating exercise practice,
- Pregnancy or breastfeeding,
- Protected adults (individuals under guardianship by court order).
- Note: participation to another concomitant clinical trial is allowed, but the patient must inform the Investigator and get an authorization from the Sponsor.
Key Trial Info
Start Date :
April 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04478175
Start Date
April 29 2021
End Date
October 5 2022
Last Update
November 17 2022
Active Locations (1)
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1
Institut Curie
Paris, France, 75005