The GOLD Study: G8 in OLDer Patients (GOLD)

April 14, 2026 updated by: Istituto Oncologico Veneto IRCCS

Prognostic Value of Baseline G8 Geriatric Assessment in Elderly Metastatic Colorectal Cancer Patients

Management of older cancer patients is challenging, due to a lack of good quality evidence to guide treatment decisions, as well as the wide variability in the level of fitness for treatment of elderly patients. Oncologists are faced with the challenge of determining the most suitable treatment for an individual taking into account their comorbidities, competing causes of death, quality of life and functional reserve.

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the western world and ranks second among the most frequent malignancies in Europe in both men and women. The incidence and mortality of CRC strongly increases with age. Approximately 60% of new cases of CRC and 70% of CRC-related deaths occur in patients aged 65 years and older, with about 40% of patients aged 75 years or older.

The oncologists' therapeutic decision-making for elderly patients with metastatic colorectal cancer (mCRC) has been largely debated in the last few years, mainly because of the lack of trial-based recommendations, due to the underrepresentation of patients more than 65 years old in clinical trials. As a consequence, therapeutic choices in this setting are frequently driven by data from retrospective, pooled and meta-analyses. These results do not necessarily reflect the general population affected with mCRC and are often limited by potential confounding factors.

It is well recognized that chronological age is not an effective criterion on which to base therapeutic decisions. Rather, treatment tolerability in an older cancer patient is primarily related to physiological or biological age, that is the level of fitness, which takes into account factors such as functional status and comorbidities. Physiological age is better assessed with a comprehensive geriatric assessment (CGA), a multidisciplinary evaluation covering domains such as cognitive and mood status, functionality, comorbidities, and nutrition. These deficits are prevalent in older patients but which may be missed with routine evaluation.

There is now strong evidence that use of a CGA assessment in a general geriatric patient population can improve health outcomes. While some form of geriatric assessment have been recommended by specialist advisory panels for all elderly patients in whom chemotherapy is considered, evidence of CGA leading to improved outcomes in a geriatric population with cancer is very limited. CGA for older patients with cancer does appear to provide information relating to prognosis, likelihood of toxicity from chemotherapy, and has been shown to influence treatment decisions. However, this approach is time-consuming, leading cancer specialists to seek an easier screening tool that can separate fit older patients with cancer, who are able to receive standard cancer treatment, from vulnerable patients that should subsequently receive a full assessment to guide tailoring of their treatment regimen.

The G8 is a simple 8-items screening tool, developed specifically for older patients with cancer. This tool, addressed by the clinician, covers multiple domains, focusing on nutritional status, mobility, neuropsychological problems, medication use, self-rated health status and age. The G8 demonstrated a good sensitivity in identifying patients with impairments across multiple domains when a cut-off of 14 points is adopted. Patients with a score < 14 would be candidate to a CGA. Nevertheless, this cut-off showed poor specificity and negative predictive value. Furthermore, some evidences suggested that the G8 might be able to predict survival, while its predictive value for treatment-related toxicities has not been extensively explored.

While literature data support a promising role for G8 as a simple cost-effective screening tool in elderly patients, to date its use in clinical practice is not widespread, and only selected centers with a focus in geriatric oncology routinely perform this assessment to enhance the baseline evaluation of patients before treatment choice.

The lack of ''real life population'' data makes it difficult to evaluate the role of G8 in the setting of common practice in an unselected population and to prove its efficacy and reliability outside selected cases.

Moreover, recent data suggest how a physical performance test, such as Timed Up and Go, could be a useful indicators of prognosis, functional decline and treatment-related complications.

This study is designed to promote a comprehensive evaluation of elderly patients before treatment decisions and to prospectively evaluate the association of G8 assessment with clinical outcome and treatment-related severe toxicity in the real life population of elderly patients with colorectal cancer in Veneto. Additionally, preliminary data on feasibility and reliability of Timed Up and Go measurement as prognostic determinant and dynamic marker, will be collected.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Padua, Italy, 35128
        • Istituto Oncologico Veneto IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly (> 70 years) patients with metastatic colorectal cancer

Description

Inclusion Criteria:

  • New diagnosis of metastatic colorectal cancer, untreated in the metastatic setting
  • Age ≥ 70 years
  • Availability of clinical data
  • Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Evaluate the prognostic value of baseline G8 screening tool for survival.
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Oncologico Veneto IRCCS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 7, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GOLD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Elderly Metastatic Colorectal Cancer Patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings