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

Not Applicable

Completed

• Conditions: Breast Cancer; Prostate Cancer; Bladder Cancer; Gastrointestinal Cancer; Lung Cancer; Ovarian Cancer
• Interventions: Other: Geriatrician review

• Registration Number: NCT02785887
• Lead Sponsor: Azienda USL 4 Prato

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

Study Timeline

• Study First Submitted: 2014-03-26
• Study Start: 2014-08-01
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Primary Completion: 2018-09-25
• Study Completion: 2018-09-25
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oncological and geriatrician review	Geriatrician review	Routine oncological care plus geriatric intervention

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Ospedale Vito Fazi; 🇮🇹 Lecce, Italy

Ospedale San Paolo; 🇮🇹 Milano, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy