Optimization of Systemic Treatment Strategies in Elderly Patients With Advanced Solid Malignancies (OptiMal)

November 18, 2020 updated by: K. Versteeg, Amsterdam UMC, location VUmc
The purpose of this study is to assess whether the presence of a Myelodysplastic Syndrome (MDS) , Idiopathic Cytopenia of Undetermined Significance (ICUS) or Idiopathic Dysplasia of Undetermined Significance (IDUS), correlates with treatment intensity and clinical outcome in older patients with advanced malignancies receiving palliative chemotherapy. We will study the relation between sarcopenia, comprehensive geriatric assessment en pharmacokinetics with treatment related toxicity as well. We hypothesize that a standardized flow cytometry test to determine bone marrow capacity, a Comprehensive Geriatric Assessment and/or measurement of human body composition with computerized tomography will provide an accurate tool to optimize treatment strategies in elderly patients with advanced malignancies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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

  • Netherlands
      • Amsterdam, Netherlands, NL-1081 HV
        • VU Medical Center

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

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients older than 70 years of age with advanced malignancies of colorectum, breast or prostate, who will start with full standard anticancer treatment as decided by their oncologist

Description

Inclusion Criteria:

  • Age ≥ 70 years
  • Diagnosis of advanced cancer of colorectum, breast or prostate
  • Standard first line palliative treatment with cytotoxic agents will be started (Folfox, Xelox, capecitabine, paclitaxel or docetaxel)
  • Estimated life expectancy ≥ 3 months
  • Able to give informed consent
  • WHO performance status ≤ 2
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the treatment and follow-up schedule; those conditions should be assessed with the patient before registration in the trial
  • No other severe medical or psychiatric conditions that in the judgment of the investigator renders the patient inappropriate for inclusion in this study.
  • Before patient registration, written informed consent must be given and documented to ICH/EUCGCP, national/local regulatory requirements and the local rules followed in our institution

Exclusion Criteria:

  • Presence of cytopenia due to iron-, vitamin B12 and folic acid deficiency or hemolysis, unless adequately supplemented.
  • Creatinine clearance ≤ 30 ml/min
  • Serum AST and ALT ≥ 2.5 x ULN, in case of liver metastases serum AST and ALT ≥ 5 x ULN
  • In case of therapy with Docetaxel/Paclitaxel serum bilirubin ≥ 1.5 x ULN

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
standard anticancer treatment
Patients older than 70 years of age with advanced malignancies of colorectum, breast or prostate, who will start with full standard anticancer treatment as decided by their oncologist.
Procedure: venapunction
Procedure: bone marrow punction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine whether the presence of a low - intermediate 1 risk MDS, IDUS or ICUS can predict for (myelo)toxicity in older patients with advanced malignancies receiving palliative chemotherapy
Time Frame: from date of study inclusion until 30 days after end of treatment
from date of study inclusion until 30 days after end of treatment

Collaborators and Investigators

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

Sponsor

Amsterdam UMC, location VUmc

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

July 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 27, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 8, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/164

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.

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