A clinical study to access safety and efficacy of TK-90 or parenteral TK-90 placebo in patients with colorectal cancer scheduled to receive bolus 5-fluorouracil and infused leucovorin.

ABSTRACT: Intervention1: Parenteral TK-90: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Control Intervention1: Parenteral TK-90 Placebo: Administered as an infusion A) Background Medication: i) LV: (Hour-0) Dose of 500 mg/m2 Intravenous infusion over two hours (window period ± 30 mins). ii) 5-FU: (Hour-1) Dose of 500 mg/m2 Intravenous bolus (window period ± 10 mins). B) TK-90 Placebo Infusion: i) First Dose: (Hour-5) Dose of 45mg/kg IV over one hour (window period ± 15 mins). ii) Second Dose: (Hour-11) Dose of 45mg/kg IV over one hour (window period ± 15 mins). Primary outcome(s): A) SOM (Severe Oral Mucositis) - Comparison of incidences of Grade 3 or 4 mucositis (WHO scale) in the treatment (TK-90) and TK-90 placebo groups. B) Duration of SOM - Days patients suffer Grades 3 and 4 oral mucositis measured by WHO scale from the start of treatment; number of days from the first occurrence of WHO Grade 3 or 4 OM through the first occurrence of non-severe (= Grade 2) without a subsequent instance of = Grade 3 OM. patients with complete study follow-up for severe OM who do not develop severe OM (grade 0-2) will be considered to have durations of 0 days.Timepoint: 48 Hr and 96 hr every week upto week 06 and at week 08 Study Design: Randomized, Parallel Group, Placebo Controlled Trial Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded

DISEASE(S): Malignant Neoplasm Of Colon, Unspecified

PROVIDER: 2738765 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR