No registrations found.
ID
Source
Brief title
Health condition
Intestinal microbiota, microbiome, Colorectal cancer treatment, chemotoxicity, respons
Intestinale microbiota, microbioom, colorectaal carcinoom behandeling, chemotoxiciteit, respons
Sponsors and support
Intervention
Outcome measures
Primary outcome
Microbiota composition before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 related to respons & chemotoxicity
Secondary outcome
Absolute microbiota abundance before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 related to respons & chemotoxicity
Background summary
Purpose
Investigate in patients with metastatic and/or irresectable colorectal cancer treated with systemic treatment with capecitabine or TAS-102 whether:
1.Intestinal microbiota composition can act as a predictor for response.
2.Intestinal microbiota composition changes during systemic treatment and its relation to chemotoxicity.
Background
Gut microbiota and host determinants evolve in symbiotic and dependent relationships resulting in a personal ecosystem. In vitro studies showed prolonged and increased response to 5-fluorouracil, a fluoropyrimidine, in the presence of a favorable microbiota composition. Capecitabine and TAS-102 are both fluoropyrimidines used for systemic treatment in colorectal cancer patients.
Methods
An explorative prospective multicenter cohort study in the Maastricht University Medical Centre+, Catharina Hospital and Zuyderland Medical Centre will be performed in 66 patients. Before, during, and after three cycles of systemic treatment with capecitabine or TAS-102, fecal samples and questionnaires (concerning compliance and chemotoxicity) will be collected. The response will be measured by CT/MRI using RECIST-criteria. Fecal microbiota composition will be analyzed with 16S rRNA next-generation sequencing. The absolute bacterial abundance will be assessed with quantitative polymerase chain reaction. Multivariate analysis will be used for statistical analysis.
Conclusions
We aim to detect a microbiota composition that predicts if patients with metastatic and/or irresectable colorectal cancer will respond to systemic treatment and/or experience zero to limited chemotoxicity. If we are able to identify a favorable microbiota composition, fecal microbiota transplantation might be the low-burden alternative to chemotherapy switch in the future.
Study objective
The microbiota composition can predict if patients with metastatic and/or irresectable CRC will respond to systemic treatment and/or experience zero to limited chemotoxicity. Secondly, we postulate that patients who retain the same favorable microbiota composition during systemic treatment will respond and/or experience zero to limited chemotoxicity.
Study design
Before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 fecal samples and questionnaires will be collected.
Intervention
An explorative prospective multicenter cohort study in the Maastricht University Medical Centre+, Catharina Hospital and Zuyderland Medical Centre will be performed in 66 patients. Before, during, and after three cycles of systemic treatment with capecitabine or TAS-102, fecal samples and questionnaires (concerning compliance and chemotoxicity) will be collected. The response will be measured by CT/MRI using RECIST-criteria. Fecal microbiota composition will be analyzed with 16S rRNA next-generation sequencing. The absolute bacterial abundance will be assessed with quantitative polymerase chain reaction. Multivariate analysis will be used for statistical analysis.
R Aarnoutse
P.O. box 5800
Maastricht 6202 AZ
The Netherlands
+31 (0)433-881558 / +316-82.01.91.05
romy.aarnoutse@mumc.nl
R Aarnoutse
P.O. box 5800
Maastricht 6202 AZ
The Netherlands
+31 (0)433-881558 / +316-82.01.91.05
romy.aarnoutse@mumc.nl
Inclusion criteria
• Patients diagnosed with metastatic and/or irresectable CRC who will be treated with oral capecitabine (with or without intravenous bevacizumab) or oral trifluridine/tipiracil (TAS-102).
• Aged 18 years or older.
• Written informed consent.
Exclusion criteria
• Proven Microsatellite instability (MSI).
• Has not received any prior systemic therapy for the treatment of CRC during the previous 4 weeks prior to start of the current line of capecitabine or TAS-102.
• Patients treated with additional systemic treatments during planned treatment period.
• Radiotherapy within past 2 weeks prior to start.
• Therapeutic antibiotic use within past 3 months prior to start.
• Renal function: calculated creatinine clearance (Cockroft-Guilt) < 30 ml/min.
•Pregnant or nursing.
•Physically or mentally incapable or incompetent.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6571 |
| NTR-old | NTR6957 |
| Other | PMID: 28444508 : METC 16-4-234 |