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Trial record 90 of 961 for:    bone tumors AND NOT metastatic | Recruiting, Not yet recruiting, Available Studies

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

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ClinicalTrials.gov Identifier: NCT01956747
Recruitment Status : Recruiting
First Posted : October 8, 2013
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
H.M.W. Verheul, VU University Medical Center

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.

Condition or disease Intervention/treatment
Colorectum Advanced Malignancies Breast Advanced Malignancies Prostate Advanced Malignancies Procedure: venapunction Procedure: bone marrow punction

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optimization of Systemic Treatment Strategies in Elderly Patients With Advanced Solid Malignancies
Study Start Date : July 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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



Primary Outcome Measures :
  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 [ Time Frame: from date of study inclusion until 30 days after end of treatment ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956747


Locations
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Netherlands
VU Medical Center Recruiting
Amsterdam, Netherlands, NL-1081 HV
Contact: H.M.W. Verheul, MD, PhD    0031-20-4444321    h.verheul@vumc.nl   
Principal Investigator: H.M.W. Verheul, MD, PhD         
Sponsors and Collaborators
VU University Medical Center

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Responsible Party: H.M.W. Verheul, Head Department Medical Oncology, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01956747     History of Changes
Other Study ID Numbers: 2013/164
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
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Neoplasms