FOLICOLOR TRIAL: Following Therapy Response Through Liquid Biopsy in Metatstatic Colorectal Cancer Patients (FOLICOLOR)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Sanne Wouters
- 電話番号：003238212441
- メール：sanne.wouters@uza.be
研究連絡先のバックアップ
- 名前：Ayla Wyninckx
- 電話番号：003232759745
- メール：ayla.wyninckx@uza.be
研究場所
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Antwerp
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Brasschaat、Antwerp、ベルギー、2930
- 募集
- AZ Klina
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Edegem、Antwerp、ベルギー、2650
- 募集
- University Hospital Antwerp
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Wilrijk、Antwerp、ベルギー、2610
- 募集
- Sint-Augustinus (ZAS)
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Antwerpen
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Mechelen、Antwerpen、ベルギー、2800
- 募集
- AZ Sint Maarten
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Henegouwen
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Charleroi、Henegouwen、ベルギー、6020
- 募集
- Grand Hôpital de Charleroi
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Oost-Vlaanderen
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Ghent、Oost-Vlaanderen、ベルギー、9000
- 募集
- AZ Maria Middelares, Ghent
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Sint-Niklaas、Oost-Vlaanderen、ベルギー、9100
- 募集
- Vitaz
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West-Vlaanderen
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Bruges、West-Vlaanderen、ベルギー、8000
- 募集
- AZ Sint Lucas, Brugge
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Kortrijk、West-Vlaanderen、ベルギー、8500
- 募集
- AZ Groeninge, Kortrijk
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：CT arm
Treatment decision guided by radiographic evaluation following the standard of care of the treating hospital.
(Control arm)
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|
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実験的：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
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Deterioration (TTD) in Quality of Life (QoL)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Progression Free Survival (PFS)
時間枠：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).
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18 months
|
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3 year overall survival
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Timon Vandamme、University Hospital, Antwerp
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 20/04/040
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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