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

NCT01956747 | Completed DMC

• 1 other identifier: 2013/164
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectum Advanced Malignancies; Breast Advanced Malignancies; Prostate Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

• 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

  from date of study inclusion until 30 days after end of treatment

Study Arms (1)

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

Interventions

venapunction PROCEDURE

standard anticancer treatment

bone marrow punction PROCEDURE

standard anticancer treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VU Medical Center

Amsterdam, NL-1081 HV, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 8, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

NL (1)