Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00165061
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2005-09-13
Brief Title:
Multi-Center Prospective Randomized Trial Comparing Standard Esophagectomy Against Chemo-Radiotherapy for Treatment of Squamous Esophageal Cancer - Early Results From the Chinese University Research Group for Esophageal Cancer CURE
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Phase 3 Multicenter Randomized Study Comparing Esophagectomy Against Definitive Chemoradiation for Treatment of Squamous Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2005-09
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:
A multicenter randomized comparison of primary esophagectomy against definitive chemoradiotherapy for the treatment of squamous esophageal cancer
Detailed Description:
Cancer of the oesophagus is notorious for its grave prognosis with an overall 5-year survival rate of 10-20 Surgical resection with curative intent remains the most effective treatment for this disease To improve the survival a better treatment approach is in need to manage patients with oesophageal cancer Unfortunately the use of preoperative adjuvant chemotherapy or adjuvant radiotherapy does not confer any survival benefit to patients with localized oesophageal cancer as proven in most randomized studies However the combination of chemotherapy and radiotherapy has greater clinical efficacy in achieving complete pathological regression of the tumour as well as the response rate as shown in our preliminary results In fact treatment of squamous oesophageal cancer by primary chemo-irradiation without surgery is now feasible
We propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer Those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease Over a 3-year period a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm Treatment outcomes will be compared on an intention-to-treat analysis basis
We propose to conduct a multi-center randomized trial to evaluate the efficacy and the patients survival by comparing primary chemo-irradiation without surgery versus standard surgical resection as the treatment for squamous oesophageal cancer Those patients with residual cancer after primary chemo-irradiation will have salvage oesophagectomy to control the disease Over a 3-year period a total of 80 patients will be recruited from 4 different hospitals with 100 patients being randomized into each treatment arm Treatment outcomes will be compared on an intention-to-treat analysis basis
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