CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 301 enrolled
Drug / intervention
adjuvant chemotherapy +3 moredrug
Likely dose
adjuvant chemotherapy 75mg/m2from record
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Search/NCT01137123
NCT01137123Phase 3Completed

A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer

Sun Yat-sen University·interventional·Posted Jun 4, 2010·Updated Mar 31, 2022

In Brief

A Phase 3 clinical trial evaluating adjuvant chemotherapy, standard two field Lymphadenectomy, and 2 other interventions for Thoracic Esophageal Squamous Cell Carcinoma. Completed, enrolled 301 participants across 1 site.

Detailed Summary

The purpose of this study is 1. To compare the effects of the two types of thoracic esophageal cancer lymphadenectomy on the staging and prognosis of resectable esophageal cancer, which defined by the International Association of esophageal disease(ISDE) - standard mediastinal lymphadenectomy,total mediastinal lymphadenectomy and three field lymphadenectomy,and to find out reasonable range of lymphadenectomy. 2. To compare the effects of Chemotherapy Group (Docetaxel + Nedaplatin) with Control Group on the prognosis of resectable thoracic esophageal cancer,and to explore the indications of adjuvant chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartApr 1, 2010
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 10.7 yearsPosted 16.1 years ago

Interventions

adjuvant chemotherapydrug

Docetaxel 75mg/m2 +Nedaplatin 75mg/m2,IV drip on day 1 of each 21 day cycle. Number of cycles: till unacceptable toxicity develops and no more than 4 cycles.

standard two field Lymphadenectomyprocedure

Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.

Total two field Lymphadenectomyprocedure

Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.

three field Lymphadenectomyprocedure

Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.