Bladder Cancer, Breast Cancer, Gastrointestinal Cancer, Lung Cancer, Ovarian Cancer, Prostate Cancer
Conditions
Keywords
Breast cancer, lung cancer, Gastrointestinal Cancer, Ovarian cancer, Prostate cancer, bladder cancer
Brief summary
This is a randomized parallel group trial designed to evaluate the impact of implementing geriatrician-prescribed interventions based on the comprehensive geriatric assessment (CGA), on the ability to deliver adequate chemotherapy treatment, as measured by relative dose intensity (RDI).
Detailed description
This randomized parallel group trial is designed to evaluate the impact of implementing geriatrician-prescribed interventions, on the ability to deliver adequate chemotherapy treatment, as measured by RDI of at least 85%, in a cohort of vulnerable \[≥1 deficit identified at CGA and/or ≥1 comorbidity Grade 3-4 as defined by Cumulative Illness Rating Scale for Geriatrics (CIRS-G)\] elderly cancer patients with early stage or advanced solid organ malignancies. Patients will be randomized using a 2:1 allocation to Arm A: routine oncological care plus geriatric intervention or Arm B: routine oncological care
Interventions
OTHERGeriatrician review
In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found
Sponsors
Azienda USL 4 Prato
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Any solid tumors 2. Either early stage disease planned for treatment with neo/adjuvant chemotherapy, or metastatic disease planned for treatment with chemotherapy and ≤ 1 previous chemotherapy treatment in the metastatic setting 3. Absence of symptomatic central nervous system (CNS) metastases 4. Eastern Cooperative Oncology group (ECOG) performance status 0-2 5. Estimated life expectancy of ≥ 12 weeks 6. At least 1 deficit identified on CGA at screening/baseline, and/or at least one comorbidity of grade 3 or 4 severity, as defined by CIRS-G 7. Written informed consent in according to International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use/Good Clinical Practice (ICH/GCP), and national/local ethics regulations 8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol and follow-up schedule
Exclusion criteria
1. Age ≤ 69 years 2. Any patients who did not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative dose intensity | 6 months | Relative dose intensity (RDI) is defined as the ratio (in percentage) of the total administered dose of chemotherapy to the standard dose of the same chemotherapy regimen, as defined by the treating centre. RDI will be calculated as the total dose delivered from the first day of cycle 1 of chemotherapy until completion of the planned chemotherapy (average of 6 months for early, 3 months for metastatic disease), or until date of relapse or death or discontinuation from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of treatment-related toxicity | every 3-4 weeks up to 6 months | Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 |
| Occurrence of hospitalization | at 6 months for early and at 3 months for metastatic disease | Documentation of hospitalization |
| Early mortality | death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease | Documentation of death |
Other
| Measure | Time frame | Description |
|---|---|---|
| Optional Translational Substudy: Blood metabolites | up to 12 months | Proton Nuclear Magnetic Resonance (H-NMR) metabolomics spectra will be derived from a 10ml fasting peripheral serum sample collected prior to commencing chemotherapy |
Countries
Italy
Outcome results
None listed