Digestive CarcinomaURACILMPACTNCT04918264
Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice
An observational study of Digestive Carcinoma, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-Fluorouracil (5-FU) or capecitabine). 5-FU is mainly catabolised by dihydropyrimidine dehydrogenase (DPD) and partial or complete DPD deficiency can cause severe adverse reactions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive Carcinoma
- What is being tested?
- Fluoropyrimidine treatment (5-FU or capecitabine) and dosage, Uracil dosage and Overall survival
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 334 participants
- Where
- 3 sitesFrance
- Study dates
- 2 Nov 2020to 15 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be included in this retrospective study if they have digestive cancer and an uracil dosage performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the three oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]. The following characteristics will be review: histology, stage (localized vs metastatic disease), chemotherapy regimen, dose percentage of fluoropyrimidine, fluoropyrimidine induced-toxicity, time to failure and overall survival.
Who may be able to join
- Digestive cancer
- An uracil dosage performed between February 2018 to January 2020
- Received at least one cycle of fluoropyrimidine-based chemotherapy in one of the three oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]).
Who cannot join
- Age limit less than 18 years
- Not treated with fluoropyrimidine based chemotherapy
- Missing data for uracil concentration or chemotherapy dosage
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hopital Edouard Heriot, Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]
Lyon, 69003
Hopital de la Croix Rousse
Lyon, 69004
Centre Hospitalier de Lyon Sud
Pierre-Bénite, 69495
About this study
Digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-Fluorouracil (5-FU) or capecitabine). 5-FU is mainly catabolised by dihydropyrimidine dehydrogenase (DPD) and partial or complete DPD deficiency can cause severe adverse reactions. Different strategies have been proposed to predict DPD deficiency; the two main approaches are phenotyping the enzyme activity (directly or indirectly), or genotyping the four main polymorphisms associated with 5-FU-toxicity. In February 2018, the French medicines agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) recommended DPD genotyping for all patients receiving fluoropyrimidine-based treatment to improve its safety as compared to the European Medicines Agency (EMA)13 and others pharmacogenetics working group.
In December 2018, a new guideline from the French cancer institute (Institut National Du Cancer, INCa) and the French health authority (Haute Autorité de Santé, HAS) recommended the measurement of the uracil blood level before genotyping DPD and dose adaptation if this level is greater than 16 ng/mL. The aim herein is to assess how this recommendation has been implemented in clinical routine. 5-FU displays a dose-response relationship regarding both its efficacy and its toxicity, did tailored-dose impair the treatment efficacy as it decreased the risk of toxicity? To address that matter we conducted a retrospective study to evaluate how fluoropyrimidine dosage is adapted to uracil concentration with an emphasis on how patients outcome were affected. We compared time to failure and overall survival between patients with an uracil concentration < 16 ng/mL and > or = 16 ng/mL.
- Conditions
- Digestive Carcinoma
- Being tested
- Fluoropyrimidine treatment (5-FU or capecitabine) and dosage, Uracil dosage, Overall survival
- Keywords
- Uracil, DPYD, Toxicity, Clinical practice, Overall survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoropyrimidine treatment (5-FU or capecitabine) and dosageDrug
In each group with an uracil dosage; at cycle 1; capecitabine or continuous 5-FU dose percentage will be evaluate retrospectively in our database
Uracil dosageOther
For each patient, uracil concentration will be evaluate and patients will be compared based on 16 ng/mL as threshold.
Overall survivalBehavioural
For each group of patient, on 16 ng/mL as threshold for uracil concentration, overall survival will be compared betwen the two groups of patients (Uracil <16 vs Uracil ≥16).
| Study group | Role | What they receive |
|---|---|---|
| Uracil concentration <16 ng/mL | Patients were included in this arm if they have digestive cancer and an uracil dosage <16 ng/mL performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the four oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]. Receives: Drug: Fluoropyrimidine treatment (5-FU or capecitabine) and dosage; Other: Uracil dosage; Behavioral: Overall survival | |
| Uracil concentration ≥16 ng/mL | Patients were included in this arm if they have digestive cancer and an uracil dosage <16 ng/mL performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the four oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]. Receives: Drug: Fluoropyrimidine treatment (5-FU or capecitabine) and dosage; Other: Uracil dosage; Behavioral: Overall survival |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival according to plasma uracil concentration
Measured: Last completion date March 30th 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start2 Nov 2020
- Primary completion10 Feb 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918264
- Sponsor's protocol ID
- 69HCL21_0489
- Acronym
- URACILMPACT
- Status last verified
- May 2021
- First submitted
- 2 Jun 2021
- Last updated
- 8 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoropyrimidine Tailored-dose Based on Uracil Concentration in Patients Treated for Digestive Carcinomas: Evaluation of Clinical Practice
- ClinicalTrials.gov ID
- NCT04918264
- Acronym / sponsor ID
- URACILMPACT / 69HCL21_0489
- Conditions
- Digestive Carcinoma
- Keywords
- Uracil, DPYD, Toxicity, Clinical practice, Overall survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- 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.
Digestive carcinomas chemotherapies regimen are mostly based on fluoropyrimidine drugs (5-Fluorouracil (5-FU) or capecitabine). 5-FU is mainly catabolised by dihydropyrimidine dehydrogenase (DPD) and partial or complete DPD deficiency can cause severe adverse reactions. Different strategies have been proposed to predict DPD deficiency; the two main approaches are phenotyping the enzyme activity (directly or indirectly), or genotyping the four main polymorphisms associated with 5-FU-toxicity. In February 2018, the French medicines agency (Agence nationale de sécurité du médicament et des produits de santé, ANSM) recommended DPD genotyping for all patients receiving fluoropyrimidine-based treatment to improve its safety as compared to the European Medicines Agency (EMA)13 and others pharmacogenetics working group.
In December 2018, a new guideline from the French cancer institute (Institut National Du Cancer, INCa) and the French health authority (Haute Autorité de Santé, HAS) recommended the measurement of the uracil blood level before genotyping DPD and dose adaptation if this level is greater than 16 ng/mL. The aim herein is to assess how this recommendation has been implemented in clinical routine. 5-FU displays a dose-response relationship regarding both its efficacy and its toxicity, did tailored-dose impair the treatment efficacy as it decreased the risk of toxicity? To address that matter we conducted a retrospective study to evaluate how fluoropyrimidine dosage is adapted to uracil concentration with an emphasis on how patients outcome were affected. We compared time to failure and overall survival between patients with an uracil concentration < 16 ng/mL and > or = 16 ng/mL.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uracil concentration <16 ng/mL | – | Drug: Fluoropyrimidine treatment (5-FU or capecitabine) and dosage, Other: Uracil dosage, Behavioral: Overall survivalPatients were included in this arm if they have digestive cancer and an uracil dosage <16 ng/mL performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the four oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]. |
| Uracil concentration ≥16 ng/mL | – | Drug: Fluoropyrimidine treatment (5-FU or capecitabine) and dosage, Other: Uracil dosage, Behavioral: Overall survivalPatients were included in this arm if they have digestive cancer and an uracil dosage <16 ng/mL performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the four oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be included in this retrospective study if they have digestive cancer and an uracil dosage performed between February 2018 to January 2020, and if they received at least one cycle of fluoropyrimidine-based chemotherapy in one of the three oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]. The following characteristics will be review: histology, stage (localized vs metastatic disease), chemotherapy regimen, dose percentage of fluoropyrimidine, fluoropyrimidine induced-toxicity, time to failure and overall survival.
Key inclusion criteria (3 listed)
- Digestive cancer
- An uracil dosage performed between February 2018 to January 2020
- Received at least one cycle of fluoropyrimidine-based chemotherapy in one of the three oncology departments (Hopital Edouard Heriot [Lyon], Centre Hospitalier de Lyon Sud [Lyon], Hopital de la Croix Rousse [Lyon]).
Key exclusion criteria (3 listed)
- Age limit less than 18 years
- Not treated with fluoropyrimidine based chemotherapy
- Missing data for uracil concentration or chemotherapy dosage
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 |
|---|---|---|
| Fluoropyrimidine treatment (5-FU or capecitabine) and dosageIn each group with an uracil dosage; at cycle 1; capecitabine or continuous 5-FU dose percentage will be evaluate retrospectively in our database | Drug | Uracil concentration <16 ng/mL, Uracil concentration ≥16 ng/mL |
| Uracil dosageFor each patient, uracil concentration will be evaluate and patients will be compared based on 16 ng/mL as threshold. | Other | Uracil concentration <16 ng/mL, Uracil concentration ≥16 ng/mL |
| Overall survivalFor each group of patient, on 16 ng/mL as threshold for uracil concentration, overall survival will be compared betwen the two groups of patients (Uracil <16 vs Uracil ≥16). | Behavioural | Uracil concentration <16 ng/mL, Uracil concentration ≥16 ng/mL |
Primary outcome
Overall survival according to plasma uracil concentration
Time frame: Last completion date March 30th 2021
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 8 Jun 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive Carcinoma, run by Hospices Civils de Lyon at 3 sites in France.
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 3 inclusion and 3 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 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Overall survival according to plasma uracil concentration (time frame: Last completion date March 30th 2021). 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 8 Jun 2021.