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

NCT ID: NCT01956747

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2019-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectum Advanced Malignancies Breast Advanced Malignancies Prostate Advanced Malignancies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

venapunction

Intervention Type PROCEDURE

bone marrow punction

Intervention Type PROCEDURE

Interventions

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venapunction

Intervention Type PROCEDURE

bone marrow punction

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role lead

Responsible Party

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K. Versteeg

Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VU Medical Center

Amsterdam, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2013/164

Identifier Type: -

Identifier Source: org_study_id