Clinical trial · Interventional
Improve the Treatment of Thoracic Esophageal Cancer
A Prospective Clinical Trial of Improving the Treatment of Thoracic Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thoracic Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant chemotherapy | Drug | Adjuvant Chemotherapy | ALIAS |
| standard two field Lymphadenectomy | Procedure | — | UNRESOLVED |
| three field Lymphadenectomy | Procedure | — | UNRESOLVED |
| Total two field Lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- ACTIVE_COMPARATOR
- label
- standard two field +follow-up
- interventionNames
- Procedure: standard two field Lymphadenectomy
- type
- EXPERIMENTAL
- label
- standard two field +adjuvant chemotherapy
- interventionNames
- Drug: adjuvant chemotherapy
- Procedure: standard two field Lymphadenectomy
- type
- EXPERIMENTAL
- label
- total two field+follow-up
- interventionNames
- Procedure: Total two field Lymphadenectomy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
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).
References
Publications (15)
- BACKGROUNDParkin 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
- BACKGROUNDUrschel 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
- BACKGROUNDPeracchia 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
- BACKGROUNDIsono 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
- BACKGROUNDKato 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
- BACKGROUNDNishihira 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
- BACKGROUNDWatanabe 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
- BACKGROUNDLaw 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.