Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-02-04 @ 7:59 AM
Study NCT ID:
NCT02938195
Status:
UNKNOWN
Last Update Posted:
2016-10-19
First Post:
2016-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase II Study of Neo-adjuvant Chemoradiotherapy for Squamous Cell Esophageal Cancer
Sponsor:
Shanghai Chest Hospital
Organization:
Study Overview
Official Title:
Phase II Study of Optimum Design of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
Status:
UNKNOWN
Status Verified Date:
2016-10
Last Known Status:
RECRUITING
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:
The investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Detailed Description:
Esophageal cancer (EC) is the eighth most common cancers in the world, with more than 480,000 new cases and 400,000 deaths occurred annually worldwide. In China, either new cases or deaths account for more than half of the world. Morever, over 90% of Chinese patients have esophageal squamous cell carcinoma (ESCC).
Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Neo-adjuvant chemoradiotherapy followed by surgery seems hopeful to improve the survival of EC. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. However,a recent meta-analysis has indicated that an increased risk of postoperative mortality and treatment-related mortality was apparent in ESCC with the treatment of neo-adjuvant chemoradiotherapy.
Compare to surgery alone,the advantage of neoadjuvant chemoradiotherapy is reflected in the significantly higher percentage of R0 resections and higher rate of pathological complete response.
Thus,the investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional radiation therapy or Intensity-modulated radiation therapy was performed. 1.8Gy/fraction, 5 fractions a week, with a total dose of 4140cgy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy:Patients will be concurrently administered with irradiation every 4 weeks with PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) for 2 cycles.
Surgery:Patients will receive operation 4-8 weeks after chemoradiotherapy.
Surgery is the main treatment of this disease, but the prognosis of patients with locally advanced esophageal cancer is rather poor. As a result of surgery alone, the 5-year survival rate of about 25% has not changed significantly in several decades.
Neo-adjuvant chemoradiotherapy followed by surgery seems hopeful to improve the survival of EC. Recently, the CROSS trial has demonstrated that preoperative chemoradiotherapy can significantly increased the overall survival of patients with EC compared with surgery alone. However,a recent meta-analysis has indicated that an increased risk of postoperative mortality and treatment-related mortality was apparent in ESCC with the treatment of neo-adjuvant chemoradiotherapy.
Compare to surgery alone,the advantage of neoadjuvant chemoradiotherapy is reflected in the significantly higher percentage of R0 resections and higher rate of pathological complete response.
Thus,the investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Radiotherapy:Patients will be conducted CT simulation, and three-dimensional radiation therapy or Intensity-modulated radiation therapy was performed. 1.8Gy/fraction, 5 fractions a week, with a total dose of 4140cgy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
Chemotherapy:Patients will be concurrently administered with irradiation every 4 weeks with PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) for 2 cycles.
Surgery:Patients will receive operation 4-8 weeks after chemoradiotherapy.
Study Oversight
Has Oversight DMC:
True
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?: