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Improve the Treatment of Thoracic Esophageal Cancer

Primary Purpose

Thoracic Esophageal Squamous Cell Carcinoma

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
adjuvant chemotherapy
standard two field Lymphadenectomy
Total two field Lymphadenectomy
three field Lymphadenectomy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age≤70 years old;
  2. Karnofsky Performance Status（KPS）≥80;
  3. Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially;
  4. Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic.
  5. The preoperative evaluation of organ function is tolerant of surgery and chemotherapy;
  6. The subject can understand and sign the informed consent form (ICF);
  7. The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N.

Exclusion Criteria:

  1. Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer;
  2. Advanced Esophageal Cancer;
  3. Prior malignancy in 5 years recently;
  4. History of previous chest radiotherapy;
  5. History of cardio-cerebral vascular accident in 6 months lately;
  6. The subject can not understand and sign the informed consent form(ICF).

Sites / Locations

  • Sun Yat-sen Uniersity Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

standard two field +follow-up

standard two field +adjuvant chemotherapy

total two field+follow-up

total two field+adjuvant chemotherapy

three field+follow-up

three field+adjuvant chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

survival rate
Disease-free survival overall survival

Secondary Outcome Measures

Full Information

First Posted
June 3, 2010
Last Updated
March 30, 2022
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01137123
Brief Title
Improve the Treatment of Thoracic Esophageal Cancer
Official Title
A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is 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. 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.
Detailed Description
According to different location of the primary lesion，the subject can be allocated to two sub-groups: The patient with upper or middle thoracic esophageal cancer may be assigned to two field(T)-total mediastinal lymphadenectomy group,which is control group in this study or three field lymphadenectomy-Abdominal + mediastinal + cervical lymphadenectomy group,which is study group in this study randomly. After the operation,the patient whose primary lesion is completely(R0) resected will be assigned to adjuvant chemotherapy group or interview group randomly.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard two field +follow-up
Arm Type
Active Comparator
Arm Title
standard two field +adjuvant chemotherapy
Arm Type
Experimental
Arm Title
total two field+follow-up
Arm Type
Experimental
Arm Title
total two field+adjuvant chemotherapy
Arm Type
Experimental
Arm Title
three field+follow-up
Arm Type
Experimental
Arm Title
three field+adjuvant chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
adjuvant chemotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
standard two field Lymphadenectomy
Other Intervention Name(s)
two field(S)
Intervention Description
Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Intervention Type
Procedure
Intervention Name(s)
Total two field Lymphadenectomy
Other Intervention Name(s)
two field(T)
Intervention Description
Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Intervention Type
Procedure
Intervention Name(s)
three field Lymphadenectomy
Other Intervention Name(s)
three field
Intervention Description
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.
Primary Outcome Measure Information:
Title
survival rate
Description
Disease-free survival overall survival
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≤70 years old; Karnofsky Performance Status（KPS）≥80; Pathological diagnosis is squamous cell carcinoma of thoracic esophageal which is treated initially; Clinical stage is c T 1 ~ 3 N 0 ~ 1 according to the results of endoscopic ultrasonography，chest and abdomen CT and neck ultrasonic. The preoperative evaluation of organ function is tolerant of surgery and chemotherapy; The subject can understand and sign the informed consent form (ICF); The following laboratory tests, made in 4 weeks before first medication, confirmed that bone marrow, liver and kidney function in line with the requirements to participate in research; Hemoglobin（HGB）≥9.0g/L; absolute neutrophils count（ANC）≥1.5×109/L; platelet count（PLT）≥100×109/L; total bilirubin（TBIL）≤1.5N;aspartate aminotransferase (AST)≤2.5N;alanine aminotransferase(ALT)≤2.5N;prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range;endogenous creatinine clearance rate(CRE)≤1.5N. Exclusion Criteria: Cervical esophageal cancer and Non-squamous cell carcinoma of thoracic esophageal cancer; Advanced Esophageal Cancer; Prior malignancy in 5 years recently; History of previous chest radiotherapy; History of cardio-cerebral vascular accident in 6 months lately; The subject can not understand and sign the informed consent form(ICF).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peng Lin, Professor
Organizational Affiliation
651, Dongfeng Road East, Guangzhou, P. R. China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Uniersity Cancer Center
City
GuangZhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

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Links:
URL
http://www.sysucc.org.cn/
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