Improve the Treatment of Thoracic Esophageal Cancer

Thoracic Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137123
• Other study ID #: 2007044
• Status: Completed
• Phase: Phase 3
• Start date: April 2010
• Est. completion date: December 2020

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma
• Thoracic Esophageal Squamous Cell Carcinoma

Intervention

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.
• 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.
• three field Lymphadenectomy
Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.

Locations

Country	Name	City	State
China	Sun Yat-sen Uniersity Cancer Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival rate	Disease-free survival; overall survival	5 years

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