Clinical Trial: A multicenter prospective study to evaluate the safety and changes in quality of life in patients with esophagus squamous cell carcinoma following low radial force stent for residual malignant irreducible stenosis after chemoradiation therapy (Japan)

Tokyo, Oct. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000057452) titled 'A multicenter prospective study to evaluate the safety and changes in quality of life in patients with esophagus squamous cell carcinoma following low radial force stent for residual malignant irreducible stenosis after chemoradiation therapy' on Oct. 30.

Study Type: Observational

Primary Sponsor: Institute - Cancer Institute Hospital of the Japanese Foundation for Cancer Research

Condition: Condition - Squamous cell carcinoma of the esophagus with residual cancerous stricture after CRT/RT, unresectable, and dysphagia score (DS) of >2, difficult oral intake and consideration for stenting Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To clarify the safety and changes in quality-of-life in low radial force stent placement for residual cancerous stenosis after chemoradiation therapy Basic objectives2 - Safety

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Residual cancerous stenosis after CRT/RT, unable to be radically resected, DS of 2 or more, and difficulty in eating an adequate diet orally, esophageal squamous cell carcinoma to be considered for stenting. Basically, stenting is performed in most cases where the normal diameter does not pass through, but it does not matter whether the normal diameter scope passes through or not. 2) Stenting is performed, or a percutaneous endoscopic gastrostomy or CV port is created or continued. 3) Age 18 years or older at the time of consent. 4) ECOG Performance Status (PS) of 0, 1, or 2. 5) Patients have been fully informed about their participation in the study and their written consent has been obtained. Key exclusion criteria - 1) Patients on peripheral infusion without stenting, percutaneous endoscopic gastrostomy, or CV port 2) Patients with a total radiotherapy dose of less than 30 Gy 3) Patients whose pathology is other than squamous cell carcinoma such as adenocarcinoma 4) Patients with fistulas such as esophagobronchial or esophagopulmonary fistulas 5) Patients with stents other than low radial force stents (Niti-S esophageal stent, Evolution esophageal stent) 6) Patients whose esophageal stricture is close to the pharynx or who have coagulation abnormalities that preclude stenting 7) Patients with infections requiring systemic treatment 8) Pregnant or possibly pregnant or breastfeeding women 9) Patients with psychosis, psychiatric symptoms, or dementia that would make it difficult for them to participate in the study 10) Other patients who are considered by the investigator to be inappropriate to participate in the study Target Size - 250

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 03 Month 31 Day Anticipated trial start date - 2025 Year 09 Month 30 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065648

Disclaimer: Curated by HT Syndication.