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Active (not recruiting) Phase 2 2024-518741-21-00

PRODIGE 34 - ADAGE: Randomised phase III study evaluating adjuvant chemotherapy after resection of stage III colon adenocarcinoma in patients aged 70 and older

Phase 2 – studying effectiveness and dosage
Conditions: colon cancer

Sponsor: Fondation Franc.Cancerologie Digestive

trial.available_in: БГ
Overview
Trial status: Authorised The dose intensity, The overall tolerance to the treatments, The time to recurrence, Overall survival, The time to decrease in autonomy, The time to decrease in the quality of life The primary endpoint is relapse-free survival (RFS). It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment.
Description
The dose intensity, The overall tolerance to the treatments, The time to recurrence, Overall survival, The time to decrease in autonomy, The time to decrease in the quality of life
Who can participate
Age group: 65+ years Gender: Female, Male Target enrollment: 973 participants
Interventions
Xeloda 150 mg film-coated tablets
Drug
ELOXATINE 5 mg/ml, solution à diluer pour perfusion
Drug
Folinic acid (as calcium folinate) 10 mg/ml solution for injection/infusion
Drug
ELVORINE 100 mg/10 mL, solution injectable
Drug
FLUOROURACILE TEVA 1000 mg/20 ml, solution à diluer pour perfusion
Drug
Locations 2
Belgium (1)
France (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
65 Years
Healthy volunteers
No
Start date
17.01.2025
Registry ID
2024-518741-21-00
Source
euclinicaltrials.eu
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