Optimization of systemic treatment strategies in elderly patients with advanced solid malignancies: OptiMal trial
Recruiting
- Conditions
- advanced cancerpalliative chemotherapy10027476
- Registration Number
- NL-OMON47698
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 85
Inclusion Criteria
Age >= 70 years; Diagnosis of advanced cancer of colorectum, breast, prostate, stomach or esophagus; Standard palliative treatment with cytotoxic agents will be started; Life expectancy >= 3 months; Able to give informed consent
Exclusion Criteria
Presence of cytopenia due to iron-,vitamin B12 and folic acid deficiency or hemolysis, unless adequately supplemented. GFR <30 ml/min; serum AST and ALT >= 2,5 ULN, in case of liver metastases serum AST and ALT >= 5 x ULN
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Toxicity of treatment due to any cause<br /><br>* Prevalence of MDS/IDUS in the studied group of patients</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Prevalence of sarcopenia in the studied group of patients<br /><br>• (Termination, postponement or dose modification) of treatment due to<br /><br>any cause<br /><br>• Overall survival<br /><br>• Response to treatment<br /><br>• Progression free survival<br /><br>• Difference in combination therapy versus monotherapy<br /><br>• Quality of life</p><br>