Investigate the Efficacy of Chemotherapy in Patients With Positive ctDNA After Surgery and Adjuvant Chemotherapy for a Stage III Colorectal Cancer
NCT ID: NCT06197425
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
1660 participants
INTERVENTIONAL
2024-01-31
2030-01-31
Brief Summary
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The main objective is to assess the efficacy on time to disease recurrence (TTR) of treating minimal residual disease diagnosed by the presence of ctDNA after full treatment (surgery + chemotherapy) in stage III or high-risk stage II colon or upper rectum adenocarcinoma
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Chemotherapy by FOLFIRI
"FOLFIRI" cures
(Irinotecan 180 mg/m2, leucovorine 400mg/m2, 5FU bolus 400 mg/m2, 5FU continuous infusion 2400 mg/m2) every 14 days for 6 months or until disease progression on imaging
BIOLOGICAL ASSESSMENT
blood sample ACE markers
Questionnaires
Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)
Thoracic-abdomino-pelvic scan or MRI
Thoracic-abdomino-pelvic scan or MRI
Chemotherapy by Trifluridine tipiracil
Trifluridine cures
Trifluridine tipiracil 35 mg/m2 bid during 5 days/w on week 1 and 2 every 4 weeks, for 6 months or until disease progression on imaging
BIOLOGICAL ASSESSMENT
blood sample ACE markers
Questionnaires
Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)
Thoracic-abdomino-pelvic scan or MRI
Thoracic-abdomino-pelvic scan or MRI
Surveillance inside the trial/control arm
BIOLOGICAL ASSESSMENT
blood sample ACE markers
Questionnaires
Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)
Thoracic-abdomino-pelvic scan or MRI
Thoracic-abdomino-pelvic scan or MRI
Surveillance outside the trial
No interventions assigned to this group
Interventions
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"FOLFIRI" cures
(Irinotecan 180 mg/m2, leucovorine 400mg/m2, 5FU bolus 400 mg/m2, 5FU continuous infusion 2400 mg/m2) every 14 days for 6 months or until disease progression on imaging
Trifluridine cures
Trifluridine tipiracil 35 mg/m2 bid during 5 days/w on week 1 and 2 every 4 weeks, for 6 months or until disease progression on imaging
BIOLOGICAL ASSESSMENT
blood sample ACE markers
Questionnaires
Quality of life questionnaires (QLQ-C30 ; EQ-5D-5L ; GPAQ)
Thoracic-abdomino-pelvic scan or MRI
Thoracic-abdomino-pelvic scan or MRI
Eligibility Criteria
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Inclusion Criteria
* Positive ctDNA screening (methylation) and confirmation (NGS) on samples collected at the 3- or 6 months follow-up visit post-adjuvant chemotherapy
* Patients ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is \>14 for patients 70 years or older)
* Subjects with WHO performance status \< 2
* No documented disease using TAP CT-scanner and liver MRI in the case of contra-indication to dye contrast (or TEP-scanner may be also used in addition depending on physicians' choice and local availabilities).
* Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
Total bilirubin ≤ 1.5 x ULN (upper limit of normal) ASAT and ALAT ≤ 2.5 x ULN Alkaline phosphatase ≤ 2.5 x ULN Creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)
* Available tumor sample for NGS analysis
* Signed written informed consent obtained prior to any study specific procedures
* Patient affiliated to a social security scheme
Exclusion Criteria
* Uncontrolled intercurrent illness
* Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 3 years
* Pregnant or breastfeeding women, women of childbearing age not having had a negative pregnancy test
* Any known specific contraindication or allergy to the treatments used in the study†
* Total or partial dihydropyrimidine dehydrogenase (DPD) deficiency (uracilemia \> 16ng/ml)
* Known Gilbert's disease (UGT1A1\*28 genotype)
* In case of concomitant use with St John's Wort related to irinotecan
* In case of bowel obstruction according related to irinotecan
* In case of recent concomitant treatment with brivudine, related to fluorouracil.
* Participation to another interventional study for postoperative therapy
* Persons deprived of liberty or under guardianship or incapable of giving consent
* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol or follow-up schedule.
18 Years
80 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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Chu Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LEPAGE PHRCK 2022
Identifier Type: -
Identifier Source: org_study_id
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