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Report for Clinical Trial NCT02017600

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase II Trial of Induction Chemotherapy With ND-420, Cisplatin and Fluorouracil Followed by Surgery in the Treatment of Patients With Localized Squamous Cell Carcinoma of the Esophagus

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.

NCT02017600 Localized Squamous Cell Carcinoma of the Esophagus
MeSH:Carcinoma Carcinoma, Squamous Cell Esophageal Neoplasms Esophageal Squamous Cell Carcinoma
HPO:Carcinoma Esophageal neoplasm Squamous cell carcinoma

4 Interventions

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: 1

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 ---


2 C938A

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 ---



HPO Nodes


HPO: