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

Breast Cancer Clinical Trial

— GIVE  

Official title:

Impact of Geriatrician-implemented Interventions on Chemotherapy Delivery in Vulnerable Elderly Patients With Early or Metastatic Solid Malignancies: the GIVE Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02785887
• Other study ID #: GIVE
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: September 25, 2018

Study information

• Verified date: February 2019
• Source: Azienda USL 4 Prato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: September 25, 2018
• Est. primary completion date: September 25, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Lung Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Italy	Ospedale Vito Fazi	Lecce
Italy	Ospedale San Paolo	Milano
Italy	Istituto Oncologico Veneto	Padova

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL 4 Prato

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optional Translational Substudy: Blood metabolites	Proton Nuclear Magnetic Resonance (H-NMR) metabolomics spectra will be derived from a 10ml fasting peripheral serum sample collected prior to commencing chemotherapy	up to 12 months
Primary	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.	6 months
Secondary	Occurrence of treatment-related toxicity	Severity will be reported based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	every 3-4 weeks up to 6 months
Secondary	Occurrence of hospitalization	Documentation of hospitalization	at 6 months for early and at 3 months for metastatic disease
Secondary	Early mortality	Documentation of death	death from any cause occurring 12 months of randomization for neo/adjuvant patients, or within 6 months for patients with metastatic disease