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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oncological and geriatrician review | Experimental | Routine oncological care plus geriatric intervention |
|
| Oncological care | No Intervention | Routine oncological care only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geriatrician review | Other | In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Occurrence of hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Biganzoli, MD | Azienda USL 4 Prato | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Vito Fazi | Lecce | 73100 | Italy | |||
| Ospedale San Paolo |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Documentation of hospitalization
| at 6 months for early and at 3 months for metastatic disease |
| 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 |
| Milan |
| 20142 |
| Italy |
| Istituto Oncologico Veneto | Padova | 35128 | Italy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |