QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters. (NCT03828227) | Clinical Trial Compass
Active — Not RecruitingPhase 3
QoL in mCRC Elderly Patients Receiving First-line Therapy Based on Simplified Geriatric Parameters.
France49 participantsStarted 2019-06-14
Plain-language summary
A national, multicenter, open-label, randomized phase III study. The trial aim is to determine the best therapeutic strategies according with the HRQoL.
Who can participate
Age range75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Signed and dated informed consent, and willing and able to comply with protocol requirements,
✓. 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,
Exclusion criteria
✕. 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
What they're measuring
1
Health-related quality of life (HRQoL) at 6 months in the "candidate group".
Timeframe: At 6 months
Trial details
NCT IDNCT03828227
SponsorGERCOR - Multidisciplinary Oncology Cooperative Group
✕. 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,