drugset / Trial / NCT02446574
Postoperative Chemoradiation in Patients With Node-positive Esophageal Squamous Cell Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
This is a unicentered phase I/II study to explore the dose of paclitaxel and cisplatin with radiation therapy, and to document the adverse events for further clinical trial.
Timeline
- Start
- 2007-07
- Primary completion
- 2016-12
- Completion
- 2016-12
Publications
- Results Rizk N, Venkatraman E, Park B, Flores R, Bains MS, Rusch V; American Joint Committee on Cancer staging system. The prognostic importance of the number of involved lymph nodes in esophageal cancer: implications for revisions of the American Joint Committee on Cancer staging system. J Thorac Cardiovasc Surg. 2006 Dec;132(6):1374-81. doi: 10.1016/j.jtcvs.2006.07.039.
- Results Korst RJ, Rusch VW, Venkatraman E, Bains MS, Burt ME, Downey RJ, Ginsberg RJ. Proposed revision of the staging classification for esophageal cancer. J Thorac Cardiovasc Surg. 1998 Mar;115(3):660-69; discussion 669-70. doi: 10.1016/S0022-5223(98)70332-0.
- Results Rice TW, Blackstone EH, Rybicki LA, Adelstein DJ, Murthy SC, DeCamp MM, Goldblum JR. Refining esophageal cancer staging. J Thorac Cardiovasc Surg. 2003 May;125(5):1103-13. doi: 10.1067/mtc.2003.170.
- Results Hagen JA, DeMeester SR, Peters JH, Chandrasoma P, DeMeester TR. Curative resection for esophageal adenocarcinoma: analysis of 100 en bloc esophagectomies. Ann Surg. 2001 Oct;234(4):520-30; discussion 530-1. doi: 10.1097/00000658-200110000-00011.
- Results Igaki H, Kato H, Tachimori Y, Nakanishi Y. Prognostic evaluation of patients with clinical T1 and T2 squamous cell carcinomas of the thoracic esophagus after 3-field lymph node dissection. Surgery. 2003 Apr;133(4):368-74. doi: 10.1067/msy.2003.76.
- Results van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
- Results Rice TW, Adelstein DJ, Chidel MA, Rybicki LA, DeCamp MM, Murthy SC, Blackstone EH. Benefit of postoperative adjuvant chemoradiotherapy in locoregionally advanced esophageal carcinoma. J Thorac Cardiovasc Surg. 2003 Nov;126(5):1590-6. doi: 10.1016/s0022-5223(03)01025-0.
- Results Liu HC, Hung SK, Huang CJ, Chen CC, Chen MJ, Chang CC, Tai CJ, Tzen CY, Lu LH, Chen YJ. Esophagectomy for locally advanced esophageal cancer, followed by chemoradiotherapy and adjuvant chemotherapy. World J Gastroenterol. 2005 Sep 14;11(34):5367-72. doi: 10.3748/wjg.v11.i34.5367.
- Results Hsu PK, Huang CS, Wang BY, Wu YC, Hsu WH. Survival benefits of postoperative chemoradiation for lymph node-positive esophageal squamous cell carcinoma. Ann Thorac Surg. 2014 May;97(5):1734-41. doi: 10.1016/j.athoracsur.2013.12.041. Epub 2014 Mar 6.
- Results Chen J, Pan J, Liu J, Li J, Zhu K, Zheng X, Chen M, Chen M, Liao Z. Postoperative radiation therapy with or without concurrent chemotherapy for node-positive thoracic esophageal squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2013 Jul 15;86(4):671-7. doi: 10.1016/j.ijrobp.2013.03.026.
- Results Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 20 mg/m2 | — |