SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02839343

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Preoperative Extended Chemotherapy vs. Chemotherapy Plus Hypofractionated Radiation Therapy for Borderline Resectable Adenocarcinoma of the Head of the Pancreas

This randomized phase II trial studies how well combination chemotherapy (mFOLFIRINOX) with or without hypofractionated radiation therapy before surgery works in patients with pancreatic cancer that can be removed by surgery. Drugs used in combination chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, and irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. It is not yet known if combination chemotherapy is more effective with or without hypofractionated radiation therapy before surgery in treating patients with pancreatic cancer.

NCT02839343 Pancreatic Adenocarcinoma Borderline Resectable Adenocarcinoma of the Head of the Pancrease
MeSH: Adenocarcinoma

4 Interventions

Name: radiation therapy

Type: Radiation

mFOLFIRINOX + radiation + surgery + FOLFOX

Name: surgery

Type: Procedure

mFOLFIRINOX + radiation + surgery + FOLFOX mFOLFIRINOX + surgery + FOLFOX

Name: mFOLFIRINOX

Description: oxaliplatin IV, irinotecan IV, leucovorin IV and 5-FU IV

Type: Drug

mFOLFIRINOX + radiation + surgery + FOLFOX mFOLFIRINOX + surgery + FOLFOX

Name: FOLFOX

Description: oxaliplatin IV, leucovorin IV and 5-FU IV

Type: Drug

mFOLFIRINOX + radiation + surgery + FOLFOX mFOLFIRINOX + surgery + FOLFOX


Primary Outcomes

Description: Defined as the number of patients who are alive at 18 months after randomization divided by the total number of evaluable patients in each arm. An evaluable patient is defined as any patient who signed informed consent, deemed eligible by central review and received any protocol-defined treatment. 95% confidence interval will be estimated based on standard method. Chi-squared test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare 18 month OS rates among treatment arms. OS within each arm will be summarized by Kaplan-Meier method. Median, 1-year and 2-year rates will be estimated based on Kaplan-Meier curves.

Measure: Overall survival (OS) rate

Time: 18 months

Secondary Outcomes

Description: Defined as the proportion of patients in whom an achieved R0 resection was achieved during surgery. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare R0 resection rate between treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between R0 resection rate and OS/progression-free survival will be assessed by log-rank test and Cox model.

Measure: Residual tumor (R)0 resection rate

Time: 24 months

Description: Defined as time from randomization to the first documentation of event where events considered are 1) disease progression, per RECIST, prior to surgery, 2) surgery with R2 resection, 3) recurrent disease following surgery, or 4) death due to any cause. Will be estimated using the method of Kaplan-Meier in each arm and compared between treatment groups using the log-rank test. The correlation between pathologic complete response (pCR) status and event-free survival time will be assessed by Cox model with landmark approach.

Measure: Event-free survival

Time: 5 years

Description: Defined as the proportion of patients in whom a pCR was confirmed by histopathologic review of the surgical specimen. Chi-square test (or Fisher's exact test if the data in contingency table is sparse) will be used to compare pCR resection rate between two treatment arms. Sensitivity analysis will be conducted among patients in cohort 1) and cohort 2). The association between pCR rate and OS/progression free survival (PFS) will be assessed by log-rank test and Cox model.

Measure: Pathologic complete rate (pCR) rate

Time: 24 months

Description: Overall adverse event rates will be compared between treatment groups using Chi-square test (or Fisher's exact test if the data in contingency table is sparse).

Measure: Incidence of adverse events assessed per Common Terminology Criteria for Adverse Events (CTCAE) version 4 and the Patient-Reported Outcomes version of the CTCAE

Time: 24 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs2853564

TERTIARY OBJECTIVES: I. To test the effect of the rs2853564 vitamin D receptor (VDR) variant on OS rate and discover novel candidate genes associated with OS and severe toxicity of chemotherapy by using genome-wide genotyping approaches.



HPO Nodes