Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients

Azienda USL 4 Prato233 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

233

Conditions

Breast Cancer Lung Cancer Ovarian Cancer Prostate Cancer Bladder Cancer Gastrointestinal Cancer

Interventions

Geriatrician reviewOTHER

In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Ospedale Vito Fazi

Lecce, Italy

Ospedale San Paolo

Milan, Italy

Istituto Oncologico Veneto

Padua, Italy

Outcomes

Primary Outcomes

Relative dose intensity

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.

Time frame: 6 months

Secondary Outcomes

Occurrence of treatment-related toxicity

Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time frame: every 3-4 weeks up to 6 months

Occurrence of hospitalization

Documentation of hospitalization

Time frame: at 6 months for early and at 3 months for metastatic disease

Early mortality

Documentation of death

Time frame: death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease

Data from ClinicalTrials.gov

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