Metastatic Colorectal Cancer (mCRC)FRUQUENTNCT06787105
Fruquintinib in Patients With Metastatic Colorectal Cancer
An observational study of Metastatic Colorectal Cancer (mCRC), run by iOMEDICO AG at 42 sites in Germany.
Trial summary
FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer (mCRC)
- How many people
- 150 participants
- Where
- 42 sitesGermany
- Study dates
- 17 Feb 2025to Dec 2027
- Phase
- Observational
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: Adult patients with mCRC receiving fruquintinib in Germany.
Who may be able to join
- Aged 18 years or older.
- Indication and decision for therapy with fruquintinib in accordance with the current German SmPC of fruquintinib as monotherapy for patients with mCRC.
- Prior treatment with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan based chemotherapies, anti VEGF therapy, and if RAS wild-type, anti EGFR therapy.
- Progression on or intolerance to treatment with either trifluridine/tipiracil and/or regorafenib.
- Other criteria according to current SmPC.
- Signed written informed consent.* * Patients are allowed to be enrolled up to 6 weeks after their first dose of fruquintinib. These patients cannot participate in the PRO assessments.
Who cannot join
- Participation in an interventional clinical trial (except follow-up) within 30 days prior to enrollment or start of treatment with fruquintinib, whatever comes first.
- Contraindications according to current SmPC.
Trial locations and contacts
42 sites in 1 country. Contact the study team or a site near you to ask about taking part.
42 sites in 1 country
Germany42 sites, 42 recruiting
- Recruiting
MVZ am Klinikum Aschaffenburg GmbH
Aschaffenburg, Bavaria, 63768
Manfred Welslau, Dr. med., +496021323450, manfred.welslau@mvz-klinikum-ab.de
Manfred Welslau, Dr. med.
- Recruiting
DRK Kliniken Berlin Köpenick Klinik für Allgemein-, Viszeral- & Minimalinvasive Chirurgie
Berlin, 12559
Patrick Stübs, Dr. med., +493030353317, p.stuebs@drk-kliniken-berlin.de
Patrick Stübs, Dr. med.
- Recruiting
Evangelisches Waldkrankenhaus Spandau Innere Medizin I
Berlin, 13589
Silke Polata, Dr. med., +493037022417, silke.polata@jsd.de
Silke Polata, Dr. med.
- Recruiting
Hämatologikum Biberach
Biberach, Baden-Wurttemberg, 88400
Leonid Basovski, Dr. med., +497351180170, basovski@mediko-bc.de
Leonid Basovski, Dr. med.
- Recruiting
MVZ für Hämatologie und Onkologie Köln Am Sachsenring GmbH
Cologne, North Rhine-Westphalia, 50677
Vangica Galkin, Dr. med., +492219318220, galkin@oncokoeln.de
Vangica Galkin, Dr. med.
- Recruiting
Ambulantes Zentrum für Hämatologie & Onkologie
Cottbus, Brandenburg, 03046
Kerstin Gutsche, Dr. med., +4935548679150, gutsche@onkologiezentrum-cottbus.de
Kerstin Gutsche, Dr. med.
- Recruiting
Onkozentrum Dresden
Dresden, Saxony, 01127
Thomas Göhler, Dr. med., +493517952550, goehler@onkozentrum.de
Thomas Göhler, Dr. med.
- Recruiting
BAG / Onkologische Gemeinschaftspraxis
Dresden, Saxony, 01307
Lutz Jacobasch, Dr. med., +4935147960368, jacobasch@onkologie-dresden.net
Lutz Jacobasch, Dr. med.
- Recruiting
Gemeinschaftspraxis Dr. Mohm / Dr. Siklaky / Mann
Dresden, Saxony, 01307
Johannes Mohm, Dr. med., +493514416018, mohm@onkopraxis.dresden.de
Johannes Mohm, Dr. med.
- Recruiting
Evang. Kliniken Essen-Mitte (KEM) Internistische Onkologie
Essen, North Rhine-Westphalia, 45136
Christian Müller, Dr. med., +4920117424001, ch.mueller@kem-med.com
Christian Müller, Dr. med.
- Recruiting
Praxis Internistischer Onkologie und Hämatologie (PIOH)
Frechen, North Rhine-Westphalia, 50226
Holger Schulz, Dr. med., +4922349995927, hschulz@pioh.de
Holger Schulz, Dr. med.
- Recruiting
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Baden-Wurttemberg, 79110
Matthias Zaiss, Dr. med., +497613868712, zaiss@onkologie-freiburg.de
Matthias Zaiss, Dr. med.
- Recruiting
Schwerpunktpraxis Hämatologie & Internistische Onkologie
Fürth, Bavaria, 90766
Alexander Petzoldt, Dr. med., +4991197922230, ap-studies@hotmail.com
Alexander Petzoldt, Dr. med.
- Recruiting
ÜBAG Onkologische Kooperation Harz GbR
Goslar, Lower Saxony, 38642
Mark-Oliver Zahn, Dr. med., +495321686123, m-o.zahn@onkologie-goslar.de
Mark-Oliver Zahn, Dr. med.
- Recruiting
Hämatologisch-Onkologische Praxis Eppendorf (HOPE)
Hamburg, 20249
Eray Gökkurt, Dr. med., +494036035220, goekkurt@hope-hamburg.de
Eray Gökkurt, Dr. med.
- Recruiting
Überörtliche Gemeinschaftspraxis Schwerpunkt Haematologie, internist Onkologie & Palliativmedizin
Hamburg, 20259
Jan Wierecky, Dr. med., +4940357177730, wierecky@onkologie-hamburg.de
Jan Wierecky, Dr. med.
- Recruiting
Onkologische Schwerpunktpraxis
Hanover, Lower Saxony, 30161
Dr. med. von der Heyde, +49 511311660, info@onkologie-am-raschplatz.de
Dr. med. von der Heyde
- Recruiting
Gemeinschaftspraxis Dr. Haytham Kamal und Dr. David C. Dorn
Hanover, Lower Saxony, 30625
Haytham Kamal, Dr. med., +495115547383, kamal@onkologiehannover.de
Haytham Kamal, Dr. med.
- Recruiting
Onkologische Schwerpunktpraxis
Heidelberg, Baden-Wurttemberg, 69115
Stefan Fuxius, Dr. med., +496221714990, stefanfuxius@gmx.de
Stefan Fuxius, Dr. med.
- Recruiting
Onkologie Hof MVZ GmbH
Hof, Bavaria, 95028
Christian Kasper, Dr. med., +499281540060, christian.kasper@onkologie-hof.de
Christian Kasper, Dr. med.
- Recruiting
SHG Klinikum Idar-Oberstein Med. Klinik I: Gastroenterologie, Nephrologie, Hämatologie, Onkologie
Idar-Oberstein, Rhineland-Palatinate, 55743
Marina Bischoff, Dr. med., +496781661590, m.bischoff@io.shg-kliniken.de
Marina Bischoff, Dr. med.
- Recruiting
Dr. Vehling-Kaiser MVZ GmbH Landshut
Landshut, Bavaria, 84036
Ursula Vehling-Kaiser, Dr. med., +49871275381, dr.vk@vehling-kaiser.de
Ursula Vehling-Kaiser, Dr. med.
- Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie GbR
Lebach, Saarland, 66822
Stefan Bauer, Dr. med., +4968819999210, stefan.bauer@oncocare-saar.de
Stefan Bauer, Dr. med.
- Recruiting
Onkologie UnterEms Leer-Emden-Papenburg Dr. L. Müller
Leer, Lower Saxony, 26789
Lothar Müller, Dr. med., +4949198791203, lothar.mueller@onkologie-ue.de
Lothar Müller, Dr. med.
- Recruiting
Hämatologie und Onkologie München-Pasing MVZ GmbH
München, Bavaria, 81241
Burkhard Schmidt, Dr. med., +49898299660, schmidt@onkologie-pasing.de
Burkhard Schmidt, Dr. med.
- Recruiting
Praxis Dr. Michl
München, Bavaria, 81479
Marlies Michl, Prof. Dr. med., +498955279260, marlies.michl@onkologie-muenchen-solln.de
Marlies Michl, Prof. Dr. med.
- Recruiting
Praxis Dr. med. Jens Uhlig
Naunhof, Saxony, 04683
Jens Uhlig, Dr. med., +4934293479976, dr.uhlig@onkologie-muldental.de
Jens Uhlig, Dr. med.
- Recruiting
MVZ Onko Medical GmbH
Neustadt am Rübenberge, Lower Saxony, 31535
Munir Rababah, Dr. med., +495032891270, munir.rababah@onko-neustadt.de
Munir Rababah, Dr. med.
- Recruiting
BAG Onkologie am Filmpark
Potsdam, Brandenburg, 14482
Annette Sauer, Dr. med., +493312009680, sauer@onkologie-am-filmpark.de
Annette Sauer
- Recruiting
Praxis für Hämatologie und internistische Onkologie
Ratingen, North Rhine-Westphalia, 40878
Arnd Nusch, Dr. med., +492051804488, nusch@aol.com
Arnd Nusch, Dr. med.
- Recruiting
MVZ für Hämatologie und Onkologie Ravensburg GmbH - Studienzentrum
Ravensburg, Baden-Wurttemberg, 88212
Tobias Dechow, Dr. med., +497522974560, dechow@onkonet.eu
Tobias Dechow, Dr. med.
- Recruiting
Schwerpunktpraxis und Tagesklinik für Hämatologie und Onkologie
Regensburg, Bavaria, 93053
Catarina Stosiek, Dr. med., +49941206030432, c.stosiek@die-onkologen.de
Catarina Stosiek, Dr. med.
- Recruiting
Klinikum Rosenheim Medizinische Klinik II
Rosenheim, Bavaria, 83022
Ulrike Kolar-Michaelis, Dr. med., +4980313656181, ulrike.kolar-michaelis@ro-med.de
Ulrike Kolar-Michaelis, Dr. med.
- Recruiting
Zentrum Ambulante Onkologie
Schorndorf, Baden-Wurttemberg, 73614
Dieter Bürkle, Dr. med., +49718186568
Dieter Bürkle, Dr. med.
- Recruiting
MVZ Kloster Paradiese GbR Schwerpunktpraxis für Hämatologie u Onkologie
Soest, North Rhine-Westphalia, 59494
Anke Wortmann, Dr. med., +4929213610034, dr.wortmann@onkologie-soest.de
Anke Wortmann, Dr. med.
- Recruiting
Onkologische Schwerpunktpraxis Speyer
Speyer, Rhineland-Palatinate, 20077
Raphael Lutz, Dr. med., +496232604460, r.lutz@onkologie-speyer.de
Raphael Lutz, Dr. med.
- Recruiting
Hämatologie - Onkologie - Stolberg
Stolberg, North Rhine-Westphalia, 52222
Matthias Groschek, +4924027668829, m.groschek@onkologie-stolberg.de
Matthias Groschek
- Recruiting
Universitätsklinikum Ulm Klinik für Innere Medizin I Gastroenterologie, Nephrologie
Ulm, Bavaria, 89081
Thomas Seufferlein, Prof. Dr. med., +4973150044500, thomas.seufferlein@uniklinik-ulm.de
Thomas Seufferlein, Prof. Dr. med.
- Recruiting
ze:ro Praxen MVZ für Innere Medizin Weinheim
Weinheim, Baden-Wurttemberg, 69469
Manuel Zink, Dr. med., +496201259570, manuel.zink@zero-praxen.de
Manuel Zink, Dr. med.
- Recruiting
KHOP - Kalkan Hämatologie Onkologie Palliativmedizin
Wermelskirchen, North Rhine-Westphalia, 42929
Dilek Kalkan, Dr. med., +492196889940, dr.kalkan@khop-rbk.de
Dilek Kalkan, Dr. med.
- Recruiting
MVZ für Onkologie und Urologie GmbH
Wilhelmshaven, Lower Saxony, 26389
Andrea Distelrath, Dr. med., +494421956000, distelrath@onko-uro.de
Andrea Distelrath, Dr. med.
- Recruiting
Praxis und Tagesklinik für Hämatologie/Onkologie
Zittau, Saxony, 02763
Mathias Schulze, Dr. med., +493583696554, Dr.mathias-schulze@onkologie-zittau.de
Mathias Schulze, Dr. med.
About this study
Official title: Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study
FRUQUENT is an observational study in Germany. The goal of the study is to evaluate how well Fruquintinib works to treat patients with metastatic colorectal cancer that have previously been treated with available standard therapies.
To this end, it will be analyzed how well patients respond to the therapy in the clinical routine. Further points of interest to the study are survival data, safety data, the use of medical care facilities, and the quality of life of patients treated with Fruquintinib.
Read more
Participants will be treated as decided by the treating physician and according to their routine practice.
FRUQUENT is accompanied by a translational research project combining real-world clinical data with foundational research to stratify patient collectives in regards to the therapeutic benefit of fruquintinib.
Read the detailed description
FRUQUENT is a prospective, multicenter, observational study in Germany, collecting real-world data of patients with metastatic colorectal cancer (mCRC) who receive fruquintinib according to the SmPC. The goal of the study is to analyze the effectiveness of the monotherapy with fruquintinib in adult patients with mCRC that have previously been treated with available standard therapies, including fluoropyrimidine, oxaliplatin-, and irintecan-based chemotherapies, anti-VEGF agents, and, if RAS wild-type, anti-EGFR agents. Moreover, the patients must have progressed on or be intolerant to treatment with either trifluridine/tipiracil or regorafenib.
All data for FRUQUENT will be obtained in routine clinical practice, allowing for a representative evaluation of the effectiveness of fruquintinib in a real-world setting. The study aims to recruit 150 patients in 50 practices (office based, oncology outpatient-centers or hospitals) to facilitate robust data.
The companion translational research project "FRUQUENT FUTURE" aims to identify patient collectives that benefit the most from a therapy with fruquintinib. To this end, archival tumor tissue and whole blood from routine blood draws is collected. Real-world clinical data on effectiveness is correlated with biomarker profiles of tumor tissues to determine biomarkers that are indicative of a response to fruquintinib. Longitudinal monitoring of circulating tumor DNA (ctDNA) will allow for an investigation of ctDNA as an indicator of benefit and response to fruquintinib.
- Conditions
- Metastatic Colorectal Cancer (mCRC)
- Keywords
- non-interventional, Fruzaqla, electronic QoL questionnaire, Real-world disease control rate, Later line, Fruquintinib
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world disease control rate (RW DCR)
The primary objective is to assess the effectiveness of fruquintinib in routine treatment. To this end, the real-world disease control rate will be analyzed, defined as the rate of complete response, partial response, or stable disease, either radiologically documented or clinically assessed by the treating physician.
Measured: Start of treatment to end of treatment (avg. 6 months)
Secondary outcomes (23)
Best response
Further effectiveness objective: Best response radiologically documented or clinically assessed by the treating physician.
Measured: Start of treatment to end of treatment (avg. 6 months)
Overall response rate (ORR)
Further effectiveness objective: ORR is defined as proportion of patients with any response (partial or complete remission) overall, radiologically documented or clinically assessed by the treating physician.
Measured: Start of treatment to end of treatment (avg. 6 months)
Time to treatment failure (TTF)
Further effectiveness objective: TTF is defined as the time from treatment start to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, and death.
Measured: Start of treatment to end of treatment (avg. 6 months)
Time to next treatment (TTNT)
Further effectiveness objective: TTNT is defined as the interval from the start of fruquintinib treatment to initiation of the next line of therapy.
Measured: Start of treatment to start of subsequent antineoplastic therapy (max. 33 months)
Progression-free survival (PFS)
Further effectiveness objective: PFS is defined as the time from start of fruiquintinib treatment to disease progression or death from any cause.
Measured: Start of treatment to disease progression or death (max. 33 months)
Overall survival (OS)
Further effectiveness objective: OS is defined as the time from first administration of fruquintinib to death from any cause.
Measured: Start of treatment to death (max. 33 months)
Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE
Safety objective: Incidence of (serious) AEs ((S)AEs) as characterized by type, frequency, severity and seriousness.
Measured: Start of treatment until 30 days after end of fruquintinib treatment (avg. 7 months)
Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) related to fruquintinib
Safety objective: Incidence of (serious) adverse drug reactions ((S)ADRs) as characterized by type, frequency, severity and seriousness.
Measured: Start of treatment to 30 days after end of fruquintinib treatment (avg. 7 months)
Quality of life (QoL): Absolute values over time from baseline to end of study
Patient-Reported Outcome (PRO) objective: Evaluation of QoL by validated EORTC QLQ-C30 questionnaire during fruquintinib treatment and follow-up period using absolute values over time from baseline to end of study (EOS).
The absolute values over time will be reported on the global health status / quality of life scale, functional scales (physical, role, emotional, cognitive, social) and symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). These scales are scored from 0 to 100. For the global health status/QoL, higher scores represent a higher QoL. For functional scales, higher scores indicate a higher/healthier level of functioning, while for symptom scales lower scores indicate a lower level of symptomatology/problems.
Measured: Baseline to (individual) end of study (max. 33 months)
Quality of life (QoL): Change from baseline over time to end of study
Patient-Reported Outcome (PRO) objective: Evaluation of QoL by validated EORTC QLQ-C30 questionnaire during fruquintinib treatment and follow-up period using changes from baseline over time to end of study (EOS).
The changes from the baseline over time will be reported on the global health status / quality of life scale, functional scales (physical, role, emotional, cognitive, social) and symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). These scales are scored from 0 to 100 and the change is reported as the difference between the scores at baseline and time of interest. For the global health status/QoL and functional scales, positive values indicate an improvement in quality of life while negative values indicate a deterioration in quality of life. For symptom scales, negative values indicate an improvement in symptom burden and positive values indicate an increase in symptom burden.
Measured: Baseline to (individual) end of study (max. 33 months)
Quality of life (QoL): Time to definitive deterioration (TTD)
Patient-Reported Outcome (PRO) objective: Evaluation of QoL by validated EORTC QLQ-C30 questionnaire during fruquintinib treatment and follow-up period using the time to definitive deterioration (TTD).
The time to definitive deterioration will be reported on the global health status / quality of life scale, functional scales (physical, role, emotional, cognitive, social) and symptom scales (fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, financial difficulties). These scales are scored from 0 to 100 and the TTD is reported as the period of time until definitive deterioration for each scale.
Measured: Baseline to (individual) end of study (max. 33 months)
Frequency of parameters affecting physicians' treatment decision making
Assessment of physicians' treatment decision making using the frequency of distinct parameters affecting therapy choice.
Measured: Baseline
Fruiquintinib therapy duration
Treatment reality objective: Duration of treatment with fruquintinib
Measured: Start of treatment to end of treatment (avg. 6 months)
Frequency of treatment modifications of fruquintinib therapy
Treatment reality objective: Frequency of treatment modifications (treatment interruptions and dose reductions) with reasons, as well as duration of treatment interruptions and number of missed doses.
Measured: Start of treatment to end of treatment (avg. 6 months)
Frequency of prior therapies according to type, setting and substance
Treatment reality objective: Frequency of previous therapies (radiation, surgery, systemic with setting: adjuvant/ neoadjuvant/ palliative) and substances for prior systemic antineoplastic therapies.
Measured: Baseline
Frequency of subsequent antineoplastic therapies
Treatment reality objective: Frequency of subsequent antineoplastic therapies including substances.
Measured: From date of end of fruquintinib treatment until end of study (max. 33 months)
Duration of first subsequent therapy
Treatment reality objective: Duration of first subsequent antineoplastic therapy after discontinuation of fruquintinib treatment.
Measured: From date of end of fruquintinib treatment until end of first subsequent therapy (max. 33 months)
Frequency of hospitalizations and emergency unit visits
Medical resource utilization objective: Frequency of hospitalizations (planned and unplanned) and emergency unit visits during fruquintinib treatment.
Measured: Start of treatment to end of treatment (avg. 6 months)
Duration of hospitalizations
Medical resource utilization objective: Duration of hospitalization during fruquintinib treatment.
Measured: Start of treatment to end of treatment (avg. 6 months)
Treatment reality objective: Time to ECOG performance status >/= 2
For patients with ECOG <2 at inclusion, the time to deterioration to ECOG performance status >/= 2 will be analysed.
Measured: From start of enrolment to end of study (max. 33 months)
Disease characteristics objective: Date of initial diagnosis, stage of initial diagnosis, date of diagnosis of advanced disease, time to diagnosis of metastatic disease
Descriptive analysis of disease characteristics, including date of initial diagnosis, stage of initial diagnosis, date of diagnosis of advanced disease, and time from initial diagnosis to diagnosis of metastatic disease for patients with M0-Status at first diagnosis.
Measured: From start of enrolment to end of recruitment (approx. 24 months)
Evaluation of prognostic and predictive biomarkers in archival tumor tissue
Correlation of effectiveness outcomes (DCR, PFS, OS) with relevant genetic alterations (e.g., with a prevalence of >5%)
Measured: Baseline
Longitudinal monitoring of circulating tumor DNA
Identification of ctDNA+ and ctDNA- status Frequency of mutated alleles in ctDNA+ patients Correlation of ctDNA+ and ctDNA- status with effectiveness outcomes (DCR, PFS, OS).
Odds ratio for risk of progression based on ctDNA+ and ctDNA- status
Measured: Baseline to end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start17 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (mCRC)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda GmbH
- Responsible party
- Sponsor
- Investigators
- Professor Dr. med. Sebastian Stintzing, Principal investigator, Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06787105
- Sponsor's protocol ID
- iOM-100523
- Acronym
- FRUQUENT
- Status last verified
- Sep 2026
- First submitted
- 16 Jan 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No