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Report for Clinical Trial NCT02017600
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Investigator will assign 53 patients who had been histologically proven localized squamous
cell carcinoma of esophagus to receive the induction chemotherapy regimen of ND-420 50 mg/m2
on day 1, cisplatin 70 mg/m2 on day1, plus fluorouracil 700 mg/m2 daily, day1 to day4, every
3 weeks for 2 cycles and then followed by surgical resection. The successful rate of complete
treatment per protocol and complete resection will be the primary variant to evaluate in our
study.
Name: ND-420
Description: ND-420 50 mg/m2 on day1
Type: Drug
Group Labels: 1 Induction Chemotherapy DCF followed by Surgery
Name: Surgery
Description: After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.
Type: Procedure
Group Labels: 1 Induction Chemotherapy DCF followed by Surgery
Name: Cisplatin
Description: cisplatin 70 mg/m2 on day1
Type: Drug
Group Labels: 1 Induction Chemotherapy DCF followed by Surgery
Name: fluorouracil
Description: fluorouracil 700 mg/m2 daily, day1 to day4
Type: Drug
Group Labels: 2 Induction Chemotherapy DCF followed by S Induction Chemotherapy DCF followed by Surgery
Primary Outcomes
Measure: the R0 resection rate of participants Time: up to three months
Secondary Outcomes
Measure: the response rate (RECIST) of participants Time: up to three months
Measure: Number of participants with adverse events as a measure of safety and tolerability Time: up to one year
Measure: the population pharmacokinetic parameters (Cmax, AUC... )of ND-420 in the participants Time: 0, 30min, 1hr of ND-420 infusion. selected randomly form one of 3hr, 7hr, 11hr and 23hr after the end of ND-420 infusion.
Measure: the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response Time: up to one year
Measure: 1-year survival rate of participants Time: up to one year
Measure: pathologic complete response rate of participants Time: up to one year
Measure: 1-year progression free survival rate of participants Time: up to one year
Measure: 1-year overall survival rate of participants Time: up to one year
Purpose: Treatment
Allocation: N/A
Single Group Assignment
There are 2 SNPs
SNPs
1 C3435T
the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response. --- C938A --- --- C3435T ---
the correlation between clinical outcomes and the potential predictive genomic biomarkers(B-tubulin mutation, p53-Arg 72Pro, Bcl2-C938A, MDR1-C3435T polymorphism, TNFRSF1B-1466, GSTP1-l105V, CYP1B1, TS-5'UTR) for tumor response. --- C938A ---