SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02017600
Developed by Shray Alag, 2019.
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 day1Type: Drug
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
Induction Chemotherapy DCF followed by Surgery
Name: Cisplatin
Description: cisplatin 70 mg/m2 on day1Type: Drug
Induction Chemotherapy DCF followed by Surgery
Name: fluorouracil
Description: fluorouracil 700 mg/m2 daily, day1 to day4Type: Drug
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
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:Carcinoma
Genes 11
PTEN CDKN1B APC MLH1 MSH2 FGFR3 KIT DKC1 RSPO1 STK11 NLRP1 hr>Esophageal neoplasm
Genes 18
ASCC1 MSR1 RNF6 RHBDF2 APC PDGFRA CTHRC1 KIT TGFBR2 STK11 DLEC1 STAT1 SDHA SDHB SDHC WWOX RAD21 FH hr>Squamous cell carcinoma
Genes 62
BLM TYR CDKN2A NUTM1 TGFBR2 KRT5 COL7A1 GTF2E2 GJB2 ERCC2 KRT14 ERCC3 CIB1 ERCC4 ERCC5 WWOX LMNA SASH1 RNF6 TINF2 ING1 SLC17A9 DOCK8 LZTS1 PSENEN FDPS NTHL1 CTSC GJB6 BRD4 POLH RECQL4 RNF113A TMC6 FERMT1 MC1R WRN TMC8 LAMA3 MPLKIP GTF2H5 WNT10A DKC1 LAMB3 NLRP1 LAMC2 SLC45A2 OCA2 XPC MMP1 TNFRSF10B DCC WRAP53 TERC TERT RSPO1 DDB2 SLX4 STAT1 MVD IL7 MVK hr>