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| Name | Class |
|---|---|
| Takeda GmbH | INDUSTRY |
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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.
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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Best response | Further effectiveness objective: Best response radiologically documented or clinically assessed by the treating physician. | Start of treatment to end of treatment (avg. 6 months) |
| Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with mCRC receiving fruquintinib in Germany.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Max D Mai, MSc | Contact | +49 761 152420 | fruquent@iomedico.com |
| Name | Affiliation | Role |
|---|---|---|
| Professor Dr. med. Sebastian Stintzing | Charité Campus Mitte Medizinische Klinik Hämatologie/Onkologie und Tumorimmunologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onkologische Schwerpunktpraxis | Recruiting | Hanover | Lower Saxony | 30161 | Germany |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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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.
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline |
| Fruiquintinib therapy duration | Treatment reality objective: Duration of treatment with fruquintinib | 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. | 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. | Baseline |
| Frequency of subsequent antineoplastic therapies | Treatment reality objective: Frequency of subsequent antineoplastic therapies including substances. | 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. | 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. | Start of treatment to end of treatment (avg. 6 months) |
| Duration of hospitalizations | Medical resource utilization objective: Duration of hospitalization during fruquintinib treatment. | 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. | 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. | 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%) | 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 | Baseline to end of study |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |