Colorectum Advanced MalignanciesOptiMalNCT01956747
Optimization of Systemic Treatment Strategies in Elderly Patients With Advanced Solid Malignancies
An observational study of Colorectum Advanced Malignancies and Breast Advanced Malignancies, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectum Advanced Malignancies, Breast Advanced Malignancies, Prostate Advanced Malignancies
- What is being tested?
- venapunction and bone marrow punction
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2013to 1 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- venapunction, bone marrow punction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venapunctionProcedure or surgery
bone marrow punctionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: venapunction; Procedure: bone marrow punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from date of study inclusion until 30 days after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJul 2013
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectum Advanced MalignanciesStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Versteeg, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956747
- Sponsor's protocol ID
- 2013/164
- Acronym
- OptiMal
- Status last verified
- Nov 2020
- First submitted
- 27 Sep 2013
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Systemic Treatment Strategies in Elderly Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01956747
- Acronym / sponsor ID
- OptiMal / 2013/164
- Conditions
- Colorectum Advanced Malignancies, Breast Advanced Malignancies, Prostate Advanced Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| standard anticancer treatment | – | Procedure: venapunction, Procedure: bone marrow punctionPatients 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venapunction | Procedure or surgery | standard anticancer treatment |
| bone marrow punction | Procedure or surgery | standard anticancer treatment |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectum Advanced Malignancies and Breast Advanced Malignancies, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.