Improve the Treatment of Thoracic Esophageal Cancer

NCT01137123 | Completed Phase 3 DMC

• 1 other identifier: 2007044
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is

1. 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. 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.

Conditions

Thoracic Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• survival rate

  1. Disease-free survival 2. overall survival

  5 years

Study Arms (6)

standard two field +follow-up

ACTIVE COMPARATOR

Procedure: standard two field Lymphadenectomy

standard two field +adjuvant chemotherapy

EXPERIMENTAL

Drug: adjuvant chemotherapy; Procedure: standard two field Lymphadenectomy

total two field+follow-up

EXPERIMENTAL

Procedure: Total two field Lymphadenectomy

total two field+adjuvant chemotherapy

EXPERIMENTAL

Drug: adjuvant chemotherapy; Procedure: Total two field Lymphadenectomy

three field+follow-up

EXPERIMENTAL

Procedure: three field Lymphadenectomy

three field+adjuvant chemotherapy

EXPERIMENTAL

Drug: adjuvant chemotherapy; Procedure: three field Lymphadenectomy

Interventions

adjuvant chemotherapy DRUG

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 +adjuvant chemotherapy; three field+adjuvant chemotherapy; total two field+adjuvant chemotherapy

standard two field Lymphadenectomy PROCEDURE

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

Also known as: two field(S)

standard two field +adjuvant chemotherapy; standard two field +follow-up

Total two field Lymphadenectomy PROCEDURE

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

Also known as: two field(T)

total two field+adjuvant chemotherapy; total two field+follow-up

three field Lymphadenectomy PROCEDURE

Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.

Also known as: three field

three field+adjuvant chemotherapy; three field+follow-up

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen Uniersity Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (15)

• 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. doi: 10.1016/s0959-8049(01)00267-2. No abstract available.

  PMID: 11602373 BACKGROUND

• 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. doi: 10.1016/s0002-9610(02)00795-x.

  PMID: 11943125 BACKGROUND

• Peracchia A, Bonavina L, Ruol A, Stein H. Esophageal cancer: a European perspective. Recent Results Cancer Res. 2000;155:119-22. doi: 10.1007/978-3-642-59600-1_12.

  PMID: 10693245 BACKGROUND

• 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. doi: 10.1159/000226971.

  PMID: 1745490 BACKGROUND

• 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. doi: 10.1016/0003-4975(91)91008-j.

  PMID: 2039322 BACKGROUND

• 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. doi: 10.1016/s0002-9610(97)00227-4.

  PMID: 9445239 BACKGROUND

• 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. Japanese.

  PMID: 9370130 BACKGROUND

• 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. doi: 10.1002/bjs.1800830134.

  PMID: 8653330 BACKGROUND

• 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. doi: 10.1016/S0140-6736(02)08651-8.

  PMID: 12049861 BACKGROUND

• 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. doi: 10.1056/NEJM199812313392704.

  PMID: 9869669 BACKGROUND

• 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. doi: 10.1093/annonc/mdg328.

  PMID: 12881388 BACKGROUND

• 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. doi: 10.1016/s0022-5223(03)00710-4.

  PMID: 14666040 BACKGROUND

• 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. doi: 10.1016/s1040-8428(01)00219-0.

  PMID: 12050023 BACKGROUND

• 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. doi: 10.1007/BF03217851.

  PMID: 9847566 BACKGROUND

• 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. doi: 10.2169/internalmedicine.38.844.

  PMID: 10563743 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Peng Lin, Professor

  651, Dongfeng Road East, Guangzhou, P. R. China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen University Cancer Center

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 4, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: March 31, 2022

Record last verified: 2021-09

Locations

CN (1)