Improve the Treatment of Thoracic Esophageal Cancer - Full Text View

Sponsor:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT01137123

Purpose

The purpose of this study is

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.
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 III

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:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

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:

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).

Contacts and Locations

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: Xu Qiao Fen +86-20-87343736 xuqf@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:

Parkin DM, Bray FI, Devesa SS. Cancer burden in the year 2000. The global picture. Eur J Cancer. 2001 Oct;37 Suppl 8:S4-66. Review. No abstract available.

Urschel JD, Vasan H, Blewett CJ. A meta-analysis of randomized controlled trials that compared neoadjuvant chemotherapy and surgery to surgery alone for resectable esophageal cancer. Am J Surg. 2002 Mar;183(3):274-9.

Peracchia A, Bonavina L, Ruol A, Stein H. Esophageal cancer: a European perspective. Recent Results Cancer Res. 2000;155:119-22.

Isono K, Sato H, Nakayama K. Results of a nationwide study on the three-field lymph node dissection of esophageal cancer. Oncology. 1991;48(5):411-20.

Kato H, Watanabe H, Tachimori Y, Iizuka T. Evaluation of neck lymph node dissection for thoracic esophageal carcinoma. Ann Thorac Surg. 1991 Jun;51(6):931-5.

Nishihira T, Hirayama K, Mori S. A prospective randomized trial of extended cervical and superior mediastinal lymphadenectomy for carcinoma of the thoracic esophagus. Am J Surg. 1998 Jan;175(1):47-51.

Watanabe H. [Necessity of cervical lymph node dissection by retrospective analysis of submucosal cancer in mid-thoracic esophagus] Nippon Geka Gakkai Zasshi. 1997 Sep;98(9):733-6. Review. Japanese.

Law SY, Fok M, Wong J. Pattern of recurrence after oesophageal resection for cancer: clinical implications. Br J Surg. 1996 Jan;83(1):107-11.

Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33.

Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84.

Polee MB, Tilanus HW, Eskens FA, Hoekstra R, Van der Burg ME, Siersema PD, Stoter G, Van der Gaast A. Phase II study of neo-adjuvant chemotherapy with paclitaxel and cisplatin given every 2 weeks for patients with a resectable squamous cell carcinoma of the esophagus. Ann Oncol. 2003 Aug;14(8):1253-7.

Keresztes RS, Port JL, Pasmantier MW, Korst RJ, Altorki NK. Preoperative chemotherapy for esophageal cancer with paclitaxel and carboplatin: results of a phase II trial. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1603-8.

Desoize B, Madoulet C. Particular aspects of platinum compounds used at present in cancer treatment. Crit Rev Oncol Hematol. 2002 Jun;42(3):317-25. Review.

Yamanaka H, Motohiro T, Michiura T, Asai A, Mori T, Hioki K. Nedaplatin and 5-FU combined with radiation in the treatment for esophageal cancer. Jpn J Thorac Cardiovasc Surg. 1998 Oct;46(10):943-8.

Yoshioka T, Gamoh M, Shineha R, Ishibashi S, Shibata H, Suzuki T, Murakawa Y, Kato S, Shimodaira H, Kato S, Ishioka C, Kanamaru R. A new combination chemotherapy with cis-diammine-glycolatoplatinum (Nedaplatin) and 5-fluorouracil for advanced esophageal cancers. Intern Med. 1999 Nov;38(11):844-8.

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:	January 31, 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 Diseases
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Diseases

Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012