Improve the Treatment of Thoracic Esophageal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01137123
First received: June 3, 2010
Last updated: October 19, 2012
Last verified: April 2010
  Purpose

The purpose of this study is

  1. To compare the effects of the three 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.

Condition Intervention Phase
Thoracic Esophageal Squamous Cell Carcinoma
Drug: adjuvant chemotherapy
Procedure: standard two field Lymphadenectomy
Procedure: Total two field Lymphadenectomy
Procedure: three field Lymphadenectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • survival rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    1. Disease-free survival
    2. overall survival


Estimated Enrollment: 2615
Study Start Date: April 2010
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard two field +follow-up Procedure: standard two field Lymphadenectomy
Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Other Name: two field(S)
Experimental: standard two field +adjuvant chemotherapy Drug: adjuvant chemotherapy
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.
Procedure: standard two field Lymphadenectomy
Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Other Name: two field(S)
Experimental: total two field+follow-up Procedure: Total two field Lymphadenectomy
Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Other Name: two field(T)
Experimental: total two field+adjuvant chemotherapy Drug: adjuvant chemotherapy
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.
Procedure: Total two field Lymphadenectomy
Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
Other Name: two field(T)
Experimental: three field+follow-up Procedure: three field Lymphadenectomy
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.
Other Name: three field
Experimental: three field+adjuvant chemotherapy Drug: adjuvant chemotherapy
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.
Procedure: three field Lymphadenectomy
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.
Other Name: three field

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.

The patient with lower thoracic esophageal cancer may be assigned to three different groups:two field(S)-standard mediastinal lymphadenectomy group, which is control group in this study,or two field(T)-total mediastinal lymphadenectomy,which is the first study group in this study,or three field lymphadenectomy group which is the second 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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137123

Contacts
Contact: Peng Ling, professor +86-20-87343314 linpeng@sysucc.org.cn
Contact: Tan Zi Hui +86-20-87343736 tanzh@sysucc.org.cn

Locations
China, Guangdong
Sun Yat-sen Uniersity Cancer Center Recruiting
GuangZhou, Guangdong, China, 510060
Contact: Peng Lin, Professor    +86-20-87343314    linpeng@sysucc.org.cn   
Contact: Jun Zeng    +86-20-87343736    zengjun@sysucc.org.cn   
Principal Investigator: Peng Lin, Professor         
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Peng Lin, Professor 651, Dongfeng Road East, Guangzhou, P. R. China
  More Information

Publications:

Responsible Party: Peng Lin, Sun Yat-sen University Cancer Center
ClinicalTrials.gov Identifier: NCT01137123     History of Changes
Other Study ID Numbers: 2007044
Study First Received: June 3, 2010
Last Updated: October 19, 2012
Health Authority: China: Ethics Committee

Keywords provided by Sun Yat-sen University:
esophageal squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 24, 2014