NCT06787105

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Feb 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

January 16, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

February 17, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 7, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

January 16, 2025

Last Update Submit

March 5, 2025

Conditions

Metastatic Colorectal Cancer (mCRC)

Keywords

non-interventionalFruzaqlaelectronic QoL questionnaireReal-world disease control rateLater lineFruquintinib

Outcome Measures

Primary Outcomes (1)

  • 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.

    Start of treatment to end of treatment (avg. 6 months)

Secondary Outcomes (19)

  • Best response

    Start of treatment to end of treatment (avg. 6 months)

  • Overall response rate (ORR)

    Start of treatment to end of treatment (avg. 6 months)

  • Time to treatment failure (TTF)

    Start of treatment to end of treatment (avg. 6 months)

  • Time to next treatment (TTNT)

    Start of treatment to start of subsequent antineoplastic therapy (max. 33 months)

  • Progression-free survival (PFS)

    Start of treatment to disease progression or death (max. 33 months)

  • +14 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with mCRC receiving fruquintinib in Germany.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Onkologische Schwerpunktpraxis

Hanover, Lower Saxony, 30161, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Professor Dr. med. Sebastian Stintzing

    Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Max D Mai, MSc

CONTACT

+49 761 152420fruquent@iomedico.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 22, 2025

Study Start

February 17, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 7, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)