Status:
ACTIVE_NOT_RECRUITING
QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Elderly Patients
Metastatic Colorectal Cancer
Eligibility:
All Genders
75+ years
Phase:
PHASE3
Brief Summary
A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
Detailed Description
Treatment cohort will be determined based on three parameters: * Serum albumin level at baseline, * ECOG Performance Status, * Mini GDS. The "Candidate" group will be defined according to (all the f...
Eligibility Criteria
Inclusion
- Signed and dated informed consent, and willing and able to comply with protocol requirements,
- Histologically proven colorectal adenocarcinoma,
- Confirmed metastatic disease,
- Patients with no detected dihydropyridine dehydrogenase (DPD) deficiency,
- No prior therapy for metastatic disease (in case of previous adjuvant chemotherapy, interval between the end of chemotherapy and relapse must be \> 6 months for fluoropyrimidine alone or \> 12 months for oxaliplatin-based chemotherapy,
- Duly documented unresectable metastatic disease i.e., not suitable for complete carcinological surgical resection,
- Age ≥ 75 years,
- ECOG PS 0-2,
- Hematological status: neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L, and hemoglobin \> 9 g/dL,
- Adequate renal function: serum creatinine level \< 150 µmol/l, and creatinine clearance (Cockcroft and Gault or MDRD formula \> 30 mL/min),
- Adequate liver function: total bilirubin level \< 1.5 x upper normal limit (ULN), serum alkaline phosphatase (ALP) level \< 5 x ULN,
- Proteinuria \< 2+ (dipstick urinalysis) or ≤ 1g/24h,
- Regular follow-up feasible. The registered patient must be treated and followed at the participating center,
- Registration in France with the French National Health Care System (including dispositive PUMA (protection Universelle Maladie).
Exclusion
- History or evidence upon physical examination of CNS metastasis (e.g. non- irradiated CNS metastasis, seizure not controlled with standard medical therapy), unless adequately treated,
- Neuropathy grade \> 1,
- Patient with known dihydropyridine dehydrogenase (DPD) deficiency or history of severe and unexpected reactions to a fluoropyrimidine-containing regimen, or in case of clinically significant active heart disease or myocardial infarction within 6 months or if patient treated with sorivudine or its clinically related analogues, such as brivudine
- Uncontrolled hypercalcemia,
- Uncontrolled hypertension (defined as systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg), or history of hypertensive crisis, or hypertensive encephalopathy,
- Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,
- History of arterial thrombotic and/or embolic event (e.g. myocardial infarction, stroke…) within 6 months prior to randomization,
- History of abdominal fistula, gastrointestinal (GI) perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to randomization,
- History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding,
- Major surgery (open biopsy, surgical resection, wound revision or any other major surgery involving entry into body cavity) or significant traumatic injury within the last 28 days prior to randomization, and/or minor surgical procedure including placement of a vascular device within 2 days of first study treatment,
- Concomitant administration of prophylactic phenytoin,
- Treatment with sorivudine or its chemically related analogues, such as brivudine,
- Patients with known allergy/hypersensitivity to any component of study drugs
- Concomitant unplanned anti-tumor treatment,
- Participation in another clinical trial with any investigational drug within 30 days prior to randomization,
- Other serious and uncontrolled non-malignant disease,
- Patient under guardianship, curatorship or under the protection of justice
Key Trial Info
Start Date :
June 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03828227
Start Date
June 14 2019
End Date
December 1 2025
Last Update
July 18 2025
Active Locations (22)
Enter a location and click search to find clinical trials sorted by distance.
1
CH Abbeville
Abbeville, France
2
CHU Amiens Hôpital sud
Amiens, France
3
Clinique de l'Europe
Amiens, France
4
CH Beauvais
Beauvais, France