search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Intestinal microbiota in colorectalcancer


- candidate number28441
- NTR NumberNTR6957
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jan-2018
- Secondary IDsMETC 16-4-234 PMID: 28444508
- Public TitleIntestinal microbiota in colorectalcancer
- Scientific TitleStudy protocol on the role of intestinal microbiota in colorectal cancer treatment: a pathway to personalized medicine 2.0.
- ACRONYMMicrobiota in CRC
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedMicrobiome, Colorectal cancer, Intestinal microbiota , Chemotoxicity
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate1-mrt-2019
- Target number of participants66
- InterventionsAn 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.
- Primary outcomeMicrobiota composition before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 related to respons & chemotoxicity
- Secondary outcomeAbsolute microbiota abundance before, during and after 3 cycles systemic treatment with capecitabine or TAS-102 related to respons & chemotoxicity
- TimepointsBefore, during and after 3 cycles systemic treatment with capecitabine or TAS-102 fecal samples and questionnaires will be collected.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdrs. R Aarnoutse
- CONTACT for SCIENTIFIC QUERIESDr M.L. Smidt
- Sponsor/Initiator Academisch Ziekenhuis Maastricht (azM)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Jules Coenegracht Sr.
- PublicationsAarnoutse, R., de Vos-Geelen, J. M. P. G. M., Penders, J., Boerma, E. G., Warmerdam, F. A. R. M., Goorts, B., Olde Damink, S. W. M., Soons, Z., Rensen, S. S. M., and Smidt, M. L. (2017) Study protocol on the role of intestinal microbiota in colorectal cancer treatment: a pathway to personalized medicine 2.0, International Journal of Colorectal Disease, 1-8.
- Brief summaryPurpose
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.
- Main changes (audit trail)
- RECORD17-jan-2018 - 27-jan-2018


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl