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

Breast Advanced Malignancies Clinical Trial

— OptiMal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956747
• Other study ID #: 2013/164
• Status: Completed
• Start date: July 2013
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2020
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Advanced Malignancies
• Colorectum Advanced Malignancies
• Neoplasms
• Prostate Advanced Malignancies

Intervention

Procedure:
• venapunction

• bone marrow punction

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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