FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients (FOLICOLOR)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
FOLICOLOR is a prospective, randomized, open-label, multicentric phase 3 study evaluating the clinical value of ctDNA-based liquid biopsy in the follow-up of patients receiving first-line therapy for metastatic colorectal cancer.
Patients with confirmed NPY methylation-based ctDNA positivity on an initial liquid biopsy sample will be randomized into two study arms:
- Control arm (CT arm): Treatment decisions are guided by radiographic evaluation using conventional CT scans.
- Study arm (LB arm): Treatment decisions are guided by serial liquid biopsy results.
All patients are followed per study protocol for 18 months from the time of inclusion.
Primary Objective:
To determine whether a liquid biopsy-guided follow-up strategy preserves quality of life (QoL) for longer, by enabling earlier detection of disease progression and more timely therapeutic adjustments, thereby reducing exposure to ineffective treatment and associated toxicity.
Secondary Objectives:
- To evaluate whether liquid biopsy allows earlier detection of progressive disease compared to conventional CT imaging (per RECIST 1.1 criteria).
- To assess time to progression and progression-free survival (PFS) in both the LB arm and CT arm, with progression defined as progressive disease (PD) per RECIST 1.1.
- To evaluate the difference in 3-year overall survival (OS) between both study arms.
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: Sanne Wouters
- Telefonnummer: 003238212441
- E-post: sanne.wouters@uza.be
Studer Kontakt Backup
- Navn: Ayla Wyninckx
- Telefonnummer: 003232759745
- E-post: ayla.wyninckx@uza.be
Studiesteder
-
-
Antwerp
-
Brasschaat, Antwerp, Belgia, 2930
- Rekruttering
- AZ Klina
-
Edegem, Antwerp, Belgia, 2650
- Rekruttering
- University Hospital Antwerp
-
Wilrijk, Antwerp, Belgia, 2610
- Rekruttering
- Sint-Augustinus (ZAS)
-
-
Antwerpen
-
Mechelen, Antwerpen, Belgia, 2800
- Rekruttering
- AZ Sint Maarten
-
-
Henegouwen
-
Charleroi, Henegouwen, Belgia, 6020
- Rekruttering
- Grand Hôpital de Charleroi
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgia, 9000
- Rekruttering
- AZ Maria Middelares, Ghent
-
Sint-Niklaas, Oost-Vlaanderen, Belgia, 9100
- Rekruttering
- Vitaz
-
-
West-Vlaanderen
-
Bruges, West-Vlaanderen, Belgia, 8000
- Rekruttering
- AZ Sint Lucas, Brugge
-
Kortrijk, West-Vlaanderen, Belgia, 8500
- Rekruttering
- AZ Groeninge, Kortrijk
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Man or woman ≥ 18 years of age at the time the informed consent is obtained
- ECOG performance status of 0-2
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in subjects with unresectable metastatic (M1) disease
- There should be at least 1 uni-dimensionally measurable (min. 10mm) using conventional crosssectional imaging techniques (CT or MRI scan). Lesion must not be chosen from a previously irradiated field, unlessnthere has been documented disease progression in that field after irradiation and prior to randomization. All sites of disease must be evaluated ≤ 28 days prior to randomization
- Adequate hematology, renal, hepatic and coagulation function (at treating physician's discretion)
- Adequate blood results for treatment (at treating physician's discretion)
- Starting a first line treatment
Exclusion Criteria:
- History of prior or concurrent central nervous system metastases
- History of other malignancy, except:
Malignancy treated with curative intent and with no known active disease present for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the treating physician.
Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease.
Adequately treated cervical carcinoma in situ without evidence of disease. Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic colorectal carcinoma including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- Prior adjuvant chemotherapy (including oxaliplatin therapy) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFR therapy (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) for the treatment of colorectal cancer ≤ 6 months prior to randomization with the following exceptions: Subjects may have received prior fluoropyrimidine therapy if administered solely for the purpose of radiosensitization for the adjuvant or neoadjuvant treatment of rectal cancer.
- Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all radiotherapy-related toxicities.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: CT arm
Treatment decision guided by radiographic evaluation following the standard of care of the treating hospital.
(Control arm)
|
|
|
Eksperimentell: Liquid Biopsy arm
Treatment decision guided by liquid biopsies.
(intervention arm)
|
The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Deterioration (TTD) in Quality of Life (QoL)
Tidsramme: 18 months
|
The primary objective of this study is to determine whether the technique of monitoring patients with liquid biopsies can ensure that patients experience a slower decline in their quality of life (and can therefore maintain a good quality of life for longer). This will be evaluated through the difference in time to deterioration (TTD) in Quality of Life (QoL) between patients in which follow-up is done based on the results of LBs (LB-arm) in comparison to the patients in which follow-up is done based on the conventional follow-up techniques (CT-arm). TTD is defined as time from randomization to the first decrease from baseline on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ-CR29) summary score by at least 10 percent. |
18 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS)
Tidsramme: 18 months
|
To compare progresion free survival between the LB-arm and the CT-arm (progression is defined as PD on CT scan according to RECIST 1.1 criteria).
|
18 months
|
|
3 year overall survival
Tidsramme: 3 year
|
To evaluate the 3-year overall survival difference between both study arms.
|
3 year
|
|
Earlier detection of progressive disease with liquid biospies
Tidsramme: 18 months
|
The proportion of patients in which progressive disease can be detected earlier based on the results of liquid biopsies in comparison to conventional CT scans (with RECIST 1.1 measurements).
|
18 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Timon Vandamme, University Hospital, Antwerp
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 20/04/040
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .