Clinical trial NCT06787105: Fruquintinib in Patients With Metastatic Colorectal Cancer
Official title: Fruquintinib in Patients With Metastatic Colorectal Cancer: A Prospective, Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Colorectal Cancer (mCRC)
Keywords: non-interventional
Fruzaqla
electronic QoL questionnaire
Real-world disease control rate
Later line
Fruquintinib
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
Collaborators: name: Takeda GmbH
First posted: 2025-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with mCRC receiving fruquintinib in Germany.

Brief 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.

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.

Participants will be treated as decided by the treating physician and according to their routine practice.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Real-world disease control rate (RW DCR)
timeFrame: Start of treatment to end of treatment (avg. 6 months)
Secondary outcomes:
measure: Best response
timeFrame: Start of treatment to end of treatment (avg. 6 months)
measure: Overall response rate (ORR)
timeFrame: Start of treatment to end of treatment (avg. 6 months)
measure: Time to treatment failure (TTF)
timeFrame: Start of treatment to end of treatment (avg. 6 months)
measure: Time to next treatment (TTNT)
timeFrame: Start of treatment to start of subsequent antineoplastic therapy (max. 33 months)
measure: Progression-free survival (PFS)
timeFrame: Start of treatment to disease progression or death (max. 33 months)
measure: Overall survival (OS)
timeFrame: Start of treatment to death (max. 33 months)
measure: Adverse events (AEs) and serious adverse events (SAEs) according to NCI CTCAE
timeFrame: Start of treatment until 30 days after end of fruquintinib treatment (avg. 7 months)
measure: Adverse drug reaction (ADR) and serious adverse drug reactions (SADR) related to fruquintinib
timeFrame: Start of treatment to 30 days after end of fruquintinib treatment (avg. 7 months)
measure: Quality of life (QoL): Absolute values over time from baseline to end of study
timeFrame: Baseline to (individual) end of study (max. 33 months)
measure: Quality of life (QoL): Change from baseline over time to end of study
timeFrame: Baseline to (individual) end of study (max. 33 months)
measure: Quality of life (QoL): Time to definitive deterioration (TTD)
timeFrame: Baseline to (individual) end of study (max. 33 months)
measure: Frequency of parameters affecting physicians' treatment decision making
timeFrame: Baseline
measure: Fruiquintinib therapy duration
timeFrame: Start of treatment to end of treatment (avg. 6 months)
measure: Frequency of treatment modifications of fruquintinib therapy
timeFrame: Start of treatment to end of treatment (avg. 6 months)
measure: Frequency of prior therapies according to type, setting and substance
timeFrame: Baseline
measure: Frequency of subsequent antineoplastic therapies
timeFrame: From date of end of fruquintinib treatment until end of study (max. 33 months)
measure: Duration of first subsequent therapy
timeFrame: From date of end of fruquintinib treatment until end of first subsequent therapy (max. 33 months)
measure: Frequency of hospitalizations and emergency unit visits
timeFrame: Start of treatment to end of treatment (avg. 6 months)
measure: Duration of hospitalizations
timeFrame: Start of treatment to end of treatment (avg. 6 months)
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Onkologische Schwerpunktpraxis
state: Niedersachsen
Study officials:
affiliation: Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie
name: Professor Dr. med. Sebastian Stintzing
role: PRINCIPAL_INVESTIGATOR
References: