a Multicentric Randomized Controlled Trial of Self-Expandable Esophageal Radiation Stent

NCT01054274 | Unknown Phase 3 DMC

• 1 other identifier: 320924197612177170
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Esophageal cancer is common in some areas , ranking as the fourth leading cause of death from cancer in China and sixth worldwide. Although the prognosis of surgical resection for esophageal cancer has been improved, more than 50% of such patients are inoperable and have to undergo palliative treatments because of late stage cancer or metastasis. Dysphagia is the predominate symptom of patients with inoperable esophageal cancer. To relieve the dysphagia and improve the quality of life of such patients, brachytherapy has previously been utilized. Recently, stent placement has been widely accepted to be an option for palliation of the symptoms due to the esophageal strictures. Brachytherapy and esophageal self-expanding stent insertion have longer benefit. Stent insertion provides fastest improvement of dysphagia.However, recurrence of the neoplastic stricture remains a challenge after stent placement, complications in later setting occur and require further endoscopic treatment. Brachytherapy has slower onset of benefit but has fewer complications and longer benefit.To combine the advantages of the immediate relief of the esophageal dysphagia with the stent placement and radiation therapy with brachytherapy, a novel esophageal stent loaded with 125I seeds has been developed in the authors' institute. The technical feasibility and safety with this new stent has been demonstrated to be adequate in a healthy rabbit model. And a small-sample and unicentric prior clinical trial in the authors' institute certificated the novel esophageal stent can relieve the dysphagia caused by advanced esophageal cancer rapidly and improve the quality of life markedly. This current multicentric randomized clinical trial is further studying the novel esophageal stent loaded with 125I seeds to see how well they work compared with a conventional covered stent in patients with malignant dysphagia caused by advanced esophageal cancer.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; dysphagia; stent; brachytherapy

Outcome Measures

Primary Outcomes (1)

• Overall survival and Median Survival

  Follow-up in intervals of 1, 3, 6, and 12 months after stent placement

Secondary Outcomes (3)

• Quality of life [ECOG performance status],Dysphagia grade [STOOLER stand],Change of the oesophageal cancer [ RECIST standard],Restenosis degree[esophagus visualization]

  Follow-up in intervals of 1, 3, 6, and 12 months after stent placement

• Pathologic change of the cancer

  Follow-up in intervals of 1, 3, 6, and 12 months after stent placement

• Successful rate of stent placement

  Follow-up in intervals of 1, 3, 6, and 12 months after stent placement

Study Arms (2)

novel stent

ACTIVE COMPARATOR

Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.

Device: novel stent

conventional covered stent

EXPERIMENTAL

Patients undergo placement of a conventional covered stent on day 1.

Device: conventional covered stent

Interventions

novel stent DEVICE

Patients undergo placement of a novel esophageal stent loaded with 125I seeds on day 1.

Also known as: self-expandable esophageal radiation stent

novel stent

conventional covered stent DEVICE

Patients undergo placement of a conventional covered stent on day 1.

Also known as: conventional stent

conventional covered stent

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Endoscopically and histologically confirmed cancer of esophagus
• Progressive dysphagia caused by esophageal cancer, and the dysphagia grade of level Ⅲ or level Ⅳ\[STOOLER stand\]
• In barium meal of esophagus, severe stricture of the cancer make the barium difficult to pass through and the superior normal esophagus broaden
• The bulk and shape of the oesophageal cancer displayed by CT three-dimensional reconstruction
• Patients with clear consciousness，Cooperation，ECOG performance status of 0,1 and 3
• Informed consent: authorization and signature

You may not qualify if:

• Poor general status,ECOG performance status of 4,
• Dysphagia not caused by esophageal cancer,
• Noncooperation or no authorization and signature.
• The superior border of cancer higher than the seventh cervical vertebrae
• Ulcerative esophageal carcinoma
• Esophageal fistulas,
• WBC less than 3000/mm3
• Severe hepatic inadequacy or renal inadequacy,

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

Related Publications (3)

• Guo JH, Teng GJ, Zhu GY, He SC, Deng G, He J. Self-expandable stent loaded with 125I seeds: feasibility and safety in a rabbit model. Eur J Radiol. 2007 Feb;61(2):356-61. doi: 10.1016/j.ejrad.2006.10.003. Epub 2006 Nov 7.

  PMID: 17085003 RESULT

• Guo JH, Teng GJ, Zhu GY, He SC, Fang W, Deng G, Li GZ. Self-expandable esophageal stent loaded with 125I seeds: initial experience in patients with advanced esophageal cancer. Radiology. 2008 May;247(2):574-81. doi: 10.1148/radiol.2472070999. Epub 2008 Mar 18.

  PMID: 18349316 RESULT

• Zhu HD, Guo JH, Mao AW, Lv WF, Ji JS, Wang WH, Lv B, Yang RM, Wu W, Ni CF, Min J, Zhu GY, Chen L, Zhu ML, Dai ZY, Liu PF, Gu JP, Ren WX, Shi RH, Xu GF, He SC, Deng G, Teng GJ. Conventional stents versus stents loaded with (125)iodine seeds for the treatment of unresectable oesophageal cancer: a multicentre, randomised phase 3 trial. Lancet Oncol. 2014 May;15(6):612-9. doi: 10.1016/S1470-2045(14)70131-7. Epub 2014 Apr 14.

  PMID: 24742740 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Deglutition Disorders

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Gao-Jun Teng, MD

  Medical School,Southeast University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gao-Jun Teng, MD

CONTACT

+86 25 83272121; gjteng@vip.sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Last Updated: April 2, 2012

Record last verified: 2009-12

Locations

CN (1)