Clinical trial NCT02785887: Impact of Geriatrician Interventions on Chemotherapy Delivery in Vulnerable Elderly Oncology Patients
Official title: Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Ovarian Cancer
Prostate Cancer
Bladder Cancer
Gastrointestinal Cancer
Keywords: Breast cancer
lung cancer
Gastrointestinal Cancer
Ovarian cancer
Prostate cancer
bladder cancer
Lead sponsor: Azienda USL 4 Prato
Sponsor class: OTHER
First posted: 2016-05-30
Enrollment: 233
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Relative dose intensity
timeFrame: 6 months
Secondary outcomes:
measure: Occurrence of treatment-related toxicity
timeFrame: every 3-4 weeks up to 6 months
measure: Occurrence of hospitalization
timeFrame: at 6 months for early and at 3 months for metastatic disease
measure: Early mortality
timeFrame: death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease
Other outcomes:
measure: Optional Translational Substudy: Blood metabolites
timeFrame: up to 12 months
Locations:
city: Lecce
country: Italy
facility: Ospedale Vito Fazi
city: Milano
country: Italy
facility: Ospedale San Paolo
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
Study officials:
affiliation: Azienda USL 4 Prato
name: Laura Biganzoli, MD
role: PRINCIPAL_INVESTIGATOR
References: