Last updated: October 22, 2024
Sponsor: Fudan University
Overall Status: Active - Recruiting
Phase
3
Condition
Colorectal Cancer
Colon Cancer
Rectal Cancer
Treatment
FOLFOXIRI Protocol
Ascorbic acid
FOLFOX Protocol
Clinical Study ID
NCT04516681
Vitamin C-GLUT3-2020
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age≥18 years, ≤75 years; Histologically proven peritoneal metastatic adenocarcinomaof colorectal cancer, unresectable metastatic disease; IHC confirmed strong positiveGLUT3; measurable disease; Eastern Cooperative Oncology Group (ECOG) performancestatus 0 to 1; Life expectancy of at least 12 weeks; ANC ≥1,500/mm3; Hemoglobin > 8g/dL; platelet ≥ 100,000/mm3; Laboratory at baseline evaluation for inclusion inthe study: creatinine ≤1.5X upper limit [if the creatinine is elevated, but ≤1.5Xthe ULN, a 24 hour creatinine clearance will be obtained, Creatinine clearance > 50mL/min (calculated according to Cockroft and Gault)]; Transaminase (AST/ALT) ≤2.5Xupper limit of normal and bilirubin levels ≤1.5X upper limit of normal without livermetastasis; Transaminase (AST/ALT) ≤5X upper limit of normal and bilirubin levels ≤1.5X upper limit of normal with liver metastasis; Written informed consent
Exclusion
Exclusion Criteria:
- Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration onstudy); Surgery (excluding diagnostic biopsy) or irradiation within 3 weeks prior tostudy entry; Administration of any investigational drug or agent/procedure, i.e.participation in another trial within 4 weeks before beginning treatment; Concurrentchronic systemic immune therapy, chemotherapy, radiation therapy (palliativeradiation therapy allowed) or hormone therapy not indicated in the study protocol;Brain metastasis (known or suspected); Pregnant or lactating women; Otheruncontrolled concomitant illness, including serious uncontrolled intercurrentinfection; Known allergy or any other adverse reaction to any of the drugs or to anyrelated compound; Previous (within 5 years) or concurrent malignancies at othersites with the exception of surgically cured or adequately treated carcinoma in-situof the cervix and basal cell carcinoma of the skin; Patients with low or moderateexpression of GLUT3.
Study Design
Total Participants: 400
Treatment Group(s): 4
Primary Treatment: FOLFOXIRI Protocol
Phase: 3
Study Start date:
December 01, 2024
Estimated Completion Date:
December 01, 2025
Connect with a study center
Fudan university shanghai cancer center
Shanhai, Shanghai 200032
ChinaActive - Recruiting

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