Our hypothesis is that assessment of bone marrow capacity reserve can predict treatment related toxicity.
ID
Bron
Verkorte titel
Aandoening
Diagnosis of advanced cancer of colorectum, breast or prostate
Gemetastaseerd Colorectaal-, borst- of prostaatkanker
Ondersteuning
Telephone: 0031-20-4444321
Email: h.verheul@vumc.nl
Telephone: 0031-20-4444321
Email: h.verheul@vumc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
-Toxicity of treatment due to any cause<br>
- Prevalence of MDS/IDUS in the studied group of patients
Achtergrond van het onderzoek
The purpose of this study is to assess whether the presence of a myelodysplastic syndrome, 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 Comprehensive Geriatric Assessment with measurement of human body composition with computerized tomography and / or a standardized flow cytometry test to determine bone marrow capacity will provide an accurate tool to optimize treatment strategies in elderly patients with advanced malignancies
Doel van het onderzoek
Our hypothesis is that assessment of bone marrow capacity reserve can predict treatment related toxicity.
Onderzoeksopzet
from date of study inclusion until 30 days after end of treatment
Onderzoeksproduct en/of interventie
All patients will be submitted to blood tests, a bone marrow (BM) examination, and comprehensive geriatric assessment prior to start of treatment. A readily available CT scan will be used to measure
lumbar skeletal muscle. In case of absence of a recent CT scan, a CT scan of the abdomen will be performed. In addition, limited pharmacokinetics (PK) will be
performed.
Publiek
H.M.W. Verheul
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4444321/300
h.verheul@vumc.nl
Wetenschappelijk
H.M.W. Verheul
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4444321/300
h.verheul@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age older 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 ¡Ý 3 months
- Able to give informed consent
- WHO performance status ¡Ü 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Presence of cytopenia due to iron-, vitamin B12 and folic acid deficiency or hemolysis, unless adequately supplemented.
- Creatinine clearance ¡Ü 30 ml/min
- Serum AST and ALT ¡Ý 2.5 x ULN, in case of liver metastases serum AST and ALT ¡Ý 5 x ULN
- In case of therapy with Docetaxel/Paclitaxel serum bilirubin ¡Ý 1.5 x ULN
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3972 |
| NTR-old | NTR4186 |
| CCMO | NL42444.029.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON47698 |