A Phase 3 interventional study of FUDR +oxaliplatin and oxaliplatin+Leucovorin+5-FU in Colorectal Cancer and Metastasis, sponsored by Xu jianmin. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-03-31.
Sponsored by Xu jianmin · Phase 3, Interventional, and Treatment
To investigate whether intraoperative intraportal chemotherapy combined with adjuvant chemotherapy as treatment could improve disease-free survival (DFS) in patients with curative colorectal cancer resection compared with adjuvant chemotherapy alone.
This is a prospective, blind (doctors who done outcome measures were masked), multi-center, 2-arm randomized controlled trial.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 700 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Xu jianmin is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients treated with intraoperative intraportal chemotherapy (IPC) plus adjuvant chemotherapy (AC; mFOLFOX6).; IPC: During the operation, one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein within 5 minutes just before ligation. AC: All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.\[1\] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
Drug: FUDR +oxaliplatin · Drug: oxaliplatin+Leucovorin+5-FU
patients treated with adjuvant chemotherapy (AC; mFOLFOX6) alone after surgery; Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy, consisting of a 2-h infusion of 85 mg/m2 oxaliplatin given simultaneously with a 2-h infusion of 400 mg/m2 LV, followed by a bolus of 400 mg/m2 5-FU, and then a continuous infusion of 2000 mg/m2 5-FU given on 2 consecutive days by intravenous pumping every 14 days for 12 cycles.\[1\] Adverse events were categorized according to National Cancer Institute Common Toxicity Criteria, version 3.0.
Drug: oxaliplatin+Leucovorin+5-FU
IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
Also known as: fluorodeoxyuridine (FUDR)
Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
Also known as: Leucovorin (LV)
disease-free survival
DFS was defined as from the date of randomization to the date of tumor recurrence or death from any cause.
Time frame: up to 5 year
overall survival
OS was measured from the date of randomization to the date of death from any cause.
Time frame: 3 year and 5 year
metastasis-free survival
MFS was defined as the time from randomization to metastasis if metastasis was the first event.
Time frame: 3 year and 5 year
adverse events of Chemotherapy and IPC
toxicity (using NCI CTC 3.0) compared with mFOLFOX6 alone.
Time frame: 6 months
This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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