Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02423811
Status:
COMPLETED
Last Update Posted:
2019-03-13
First Post:
2015-04-19
Brief Title:
Fursultiamine in Esophageal Squamous Cell Carcinoma Patients Who Receive Concurrent Chemoradiotherapy
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
To Study the Effect of Fursultiamine in Esophageal Squamous Cell Carcinoma Patients Who Receive Concurrent Chemoradiotherapy
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Esophageal cancer is a common and fatal malignancy It is the eighth most common incident cancer and the sixth leading cause of cancer death in the world In Taiwan esophageal cancer was newly diagnosed in 2199 patients and was the cause of 1507 deaths in 2011 Squamous cell carcinoma is the predominant histological tumor type accounting for about 90 of the cases Esophageal squamous cell carcinoma ESCC is an aggressive disease characterized with extensive local growth and frequent metastases Concurrent chemoradiotherapy CCRT with or without surgery is the treatment option for locally advanced ESCC Further target therapy is used in conjunction with CCRT and surgery in ESCC since several years ago However the therapeutic outcomes are not satisfactory due to the emergence of chemo-radioresistance It is imperative to investigate new biomarkers and to find novel treatment targets in ESCC
A small population of tumor-initiating cells or cancer stem cells CSCs possess some biological functions like normal stem cells including self-renewal asymmetric cell division slowly proliferation rate and drug-resistance CSCs from many primary tumors and cell lines express specific stem cell markers including Oct4 Sox2 Nanog CD133 promimin-1 Nestin CD44 CD24 ALDH Aldehyde dehydrogenase and c-Kit There are many evidences that CSCs are responsible for tumor initiation progression and metastasis CSCs are also believed to have important roles in cancer recurrence due to their resistance to anti-cancer drugs and radiation CSCs express high levels of ATP-binding cassette ABC transporters ABC transporter can pump cytotoxic drugs out of cells and is one important mechanism of multidrug resistance in CSCs In addition CSCs have high reactive oxygen species ROS scavenger expression to remove ROS produced from irradiation therapy
Fursultiamine also known as thiamine tetrahydrofurfuryl disulfide TTFD is a derivative of vitamin B and currently used for nutrition supplement The investigators have identified that Fursultiamine suppressed OCT-4 SOX-2 NANOG expression and decreased ABCB1 and ABCG2 in tumor sphere of ESCC cell lines In this project the investigators will conduct a prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in ESCC patients Stem cell markers in clinical specimens collected before and after CCRT will be evaluated
A small population of tumor-initiating cells or cancer stem cells CSCs possess some biological functions like normal stem cells including self-renewal asymmetric cell division slowly proliferation rate and drug-resistance CSCs from many primary tumors and cell lines express specific stem cell markers including Oct4 Sox2 Nanog CD133 promimin-1 Nestin CD44 CD24 ALDH Aldehyde dehydrogenase and c-Kit There are many evidences that CSCs are responsible for tumor initiation progression and metastasis CSCs are also believed to have important roles in cancer recurrence due to their resistance to anti-cancer drugs and radiation CSCs express high levels of ATP-binding cassette ABC transporters ABC transporter can pump cytotoxic drugs out of cells and is one important mechanism of multidrug resistance in CSCs In addition CSCs have high reactive oxygen species ROS scavenger expression to remove ROS produced from irradiation therapy
Fursultiamine also known as thiamine tetrahydrofurfuryl disulfide TTFD is a derivative of vitamin B and currently used for nutrition supplement The investigators have identified that Fursultiamine suppressed OCT-4 SOX-2 NANOG expression and decreased ABCB1 and ABCG2 in tumor sphere of ESCC cell lines In this project the investigators will conduct a prospective phase II study to investigate the effect of Fursultiamine combined with CCRT in ESCC patients Stem cell markers in clinical specimens collected before and after CCRT will be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None