A Phase 2 interventional study of FOLFOXIRI in Colonic Neoplasms and Drug Therapy, sponsored by China Medical University, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by China Medical University, China · Phase 2, Interventional, and Treatment
To evaluate the efficacy and safety of neoadjuvant FOLFOXIRI chemotherapy (irinotecan, oxaliplatin and fluorouracil) in the patients with locally advanced colon cancer.
For the patients with locally advanced colon cancer, adjuvant FOLFOX and XELOX chemotherapy have become standard treatment. However, 30% - 40% patients suffered from local recurrence or distant metastasis after this standard treatment. Neoadjuvant chemotherapy could shrink tumors, eliminate micrometastasis, reduce surgical trauma and accelerate recovery. Hence, we evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy in treating patients with locally advanced colon cancer.
In this prospective study, 30 patients with locally advanced colon cancer will be treated with 4 cycles of neoadjuvant FOLFOXIRI chemotherapy followed by surgical resection. PET-CT scanning will be performed before and after the neoadjuvant FOLFOXIRI chemotherapy to assess SUVmax changes. The ctDNA in peripheral blood before and after each cycle of neoadjuvant FOLFOXIRI chemotherapy will be detected. In the course of treatment, safety evaluation will be carried out according to adverse reaction classification (CTCAE) 4. 0.
Neutrophil count≥1.5×10\^9/L Platelet count≥90×10\^9/L Hemoglobin≥90g/L Total bilirubin (TBI) ≤ 1.5 * ULN Alanine aminotransferase (ALT)≤2.5 * ULN Aspartate aminotransferase (AST)≤2.5 * ULN Alkaline phosphatase (ALP)≤2.5 * ULN
Exclusion Criteria:
Patients received 4 cycles of neoadjuvant FOLFOXIRI chemotherapy before surgical resection.
Drug: FOLFOXIRI
Irinotecan 150 mg/m\^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m\^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m\^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m\^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)
Also known as: Irinotecan, Oxaliplatin, 5-Fluorouracil
The ratio of tumor downstaging to stage 0 and stage I
Tumor downstaging from stage II or III to pathologic complete response (stage 0) and stage I
Time frame: 2 years
Tumor regression grade (TRG)
The level of tumor regression under pathological examination
Time frame: 2 years
Disease free survival
Estimated from the date of surgery to the date of recurrence
Time frame: 3 years
Overall survival time
Estimated from the date of enrollment to death from any cause
Time frame: 3 years
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The grade of toxicity will be assessed using the NCI-CTCAE version 4.0
Time frame: 3 years
ctDNA change
The relationship between ctDNA and survival will be evaluated
Time frame: 3 years
SUVmax changes
Tumor metabolic response through FDG-PET examination before and after 4 cycles of neoadjuvant FOLFOXIRI chemotherapy
Time frame: At the begin of Cycle 1 and the end of Cycle 4 (each cycle is 14 days)
Quality of life (QLQ C30)
Scores according to EORTC QLQ-C30 scoring manual
Time frame: Every 2 weeks after the first treatment until 3 years
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
China Medical University, China