Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06598917
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Maintenance Chemotherapy With S-1 Locally Advanced Esophageal Cancer Receiving Definitive CCRT
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase II Study of Maintenance Chemotherapy With S-1 in Patients With Locally Advanced Esophageal Cancer Receiving Definitive Concurrent Chemoradiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II study of definitive concurrent chemoradiotherapy follows consolidative chemotherapy with S1 for locally advanced unresectable esophageal cancer
Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT
The aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1
The primary endpoint is overall survival OS rates at 24 months defined as the proportion of patients who have not experienced death from any cause at months With a sample size of 60 patients the study had a power of 80 assuming 2-year OS of 45 in the experimental arm and 30 in the historical control with a one-sided significance level of 5
Our treatment strategy is to perform maintenance chemotherapy with S-1 in patients with locally advanced esophageal cancer receiving dCCRT
The aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1
The primary endpoint is overall survival OS rates at 24 months defined as the proportion of patients who have not experienced death from any cause at months With a sample size of 60 patients the study had a power of 80 assuming 2-year OS of 45 in the experimental arm and 30 in the historical control with a one-sided significance level of 5
Detailed Description:
Esophageal cancer is an aggressive malignant disease ranking seventh in incidence and sixth in mortality among all cancers The lack of a serosa layer in the esophagus allows tumor regional spread to nearby organs and lymph nodes While radical surgery was historically the preferred treatment for esophageal cancer 50 to 60 of patients are deemed unsuitable for surgical resection at diagnosis due to being in an advanced stage of the disease Definitive chemo-radiotherapy dCCRT combining platinum-based chemotherapy with taxanes or fluoropyrimidine is the standard treatment for unresectable locally advanced ESCC Despite this survival outcomes with the current dCCRT standard are suboptimal and nearly all patients ultimately experience tumor progression
Intensifying treatment by applying consolidative chemotherapy CCT after dCCRT may in theory enhance outcomes for these patients A Systematic Review and Meta-Analysis report short-time survival benefit of additional CCT compared to CCRT alone for patients with unresectable esophageal cancer The CCRT-CCT group could significantly reduce the risk of distant metastases and improved 3-year OS rate comparing with CCRT alone Another population-based cohort study also showed that CCT was associated with significantly improved OS for locally advanced ESCC patients treated with dCCRT
As an oral fluoropyrimidine Golfer is designed to have enhanced anticancer activity and reduced toxicity10 In the large phase 3 randomized clinical trial CRT with was tolerable and provided significant benefits over RT alone in older patients with esophageal cancer In another similar study of radiotherapy concurrent with and followed by oral S-1 chemotherapy concurrent S-1 improved survival outcomes without additional treatment related toxic effects In this trial consolidated S-1 administrated a total of 4 cycles The maintenance chemotherapy using S-1MC-S1 in patients with N3 stage nasopharyngeal carcinoma achieved superior survival The MC-S1 was administered for at least 12 cycles The toxicities of MC-S1 were mild and tolerable
However whether or not dCCRT follow maintenance therapy with S-1 improve the survival outcomes of patients with locally advanced unresectable esophageal cancer are unclear Therefore the aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1 The primary endpoint is overall survival OS rates at 24 months defined as the proportion of patients who have not experienced death from any cause at months With a sample size of 60 patients the study had a power of 80 assuming 2-year OS of 45 in the experimental arm and 30 in the historical control with a one-sided significance level of 5
Intensifying treatment by applying consolidative chemotherapy CCT after dCCRT may in theory enhance outcomes for these patients A Systematic Review and Meta-Analysis report short-time survival benefit of additional CCT compared to CCRT alone for patients with unresectable esophageal cancer The CCRT-CCT group could significantly reduce the risk of distant metastases and improved 3-year OS rate comparing with CCRT alone Another population-based cohort study also showed that CCT was associated with significantly improved OS for locally advanced ESCC patients treated with dCCRT
As an oral fluoropyrimidine Golfer is designed to have enhanced anticancer activity and reduced toxicity10 In the large phase 3 randomized clinical trial CRT with was tolerable and provided significant benefits over RT alone in older patients with esophageal cancer In another similar study of radiotherapy concurrent with and followed by oral S-1 chemotherapy concurrent S-1 improved survival outcomes without additional treatment related toxic effects In this trial consolidated S-1 administrated a total of 4 cycles The maintenance chemotherapy using S-1MC-S1 in patients with N3 stage nasopharyngeal carcinoma achieved superior survival The MC-S1 was administered for at least 12 cycles The toxicities of MC-S1 were mild and tolerable
However whether or not dCCRT follow maintenance therapy with S-1 improve the survival outcomes of patients with locally advanced unresectable esophageal cancer are unclear Therefore the aim of this study is to evaluate the efficacy and side effects of patients with locally advanced unresectable esophageal cancer after dCCRT with platinum-based chemotherapy follow maintenance therapy with S-1 The primary endpoint is overall survival OS rates at 24 months defined as the proportion of patients who have not experienced death from any cause at months With a sample size of 60 patients the study had a power of 80 assuming 2-year OS of 45 in the experimental arm and 30 in the historical control with a one-sided significance level of 5
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