FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients (FOLICOLOR)
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Sanne Wouters
- 전화번호: 003238212441
- 이메일: sanne.wouters@uza.be
연구 연락처 백업
- 이름: Ayla Wyninckx
- 전화번호: 003232759745
- 이메일: ayla.wyninckx@uza.be
연구 장소
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Antwerp
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Brasschaat, Antwerp, 벨기에, 2930
- 모병
- AZ Klina
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Edegem, Antwerp, 벨기에, 2650
- 모병
- University Hospital Antwerp
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Wilrijk, Antwerp, 벨기에, 2610
- 모병
- Sint-Augustinus (ZAS)
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Antwerpen
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Mechelen, Antwerpen, 벨기에, 2800
- 모병
- AZ Sint Maarten
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Henegouwen
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Charleroi, Henegouwen, 벨기에, 6020
- 모병
- Grand Hôpital de Charleroi
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, 벨기에, 9000
- 모병
- AZ Maria Middelares, Ghent
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Sint-Niklaas, Oost-Vlaanderen, 벨기에, 9100
- 모병
- Vitaz
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West-Vlaanderen
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Bruges, West-Vlaanderen, 벨기에, 8000
- 모병
- AZ Sint Lucas, Brugge
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Kortrijk, West-Vlaanderen, 벨기에, 8500
- 모병
- AZ Groeninge, Kortrijk
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: CT arm
Treatment decision guided by radiographic evaluation following the standard of care of the treating hospital.
(Control arm)
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실험적: Liquid Biopsy arm
Treatment decision guided by liquid biopsies.
(intervention arm)
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The LB arm is the intervention group where the evaluation of therapy is guided by Liquid Biopsy results
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Deterioration (TTD) in Quality of Life (QoL)
기간: 18 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression Free Survival (PFS)
기간: 18 months
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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).
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18 months
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3 year overall survival
기간: 3 year
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To evaluate the 3-year overall survival difference between both study arms.
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3 year
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Earlier detection of progressive disease with liquid biospies
기간: 18 months
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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).
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18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Timon Vandamme, University Hospital, Antwerp
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 20/04/040
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