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Report for Clinical Trial NCT02017600
Developed by Shray Alag, 2020-2021.
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 ---