Clinical Trial: A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer (Japan)

Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063370) titled 'A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer' on Oct. 22.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Kyoto University

Condition: Condition - Biliary tract cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the feasibility and safety of postoperative adjuvant chemoradiotherapy (S-1 plus radiotherapy) for the prevention of recurrence in patients with biliary tract cancer who have undergone curative-intent resection with biliary reconstruction and have pathologically positive resection margins, including those who achieved negative margins following additional resection. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - chemoradiation therapy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients who have undergone curative-intent resection with biliary reconstruction (hepatectomy with bile duct resection, extrahepatic bile duct resection, pancreaticoduodenectomy, or hepatopancreatoduodenectomy) and have been histopathologically diagnosed with biliary tract cancer (perihilar cholangiocarcinoma, distal cholangiocarcinoma, gallbladder cancer, ampullary carcinoma, or intrahepatic cholangiocarcinoma). Patients with positive resection margins at the initial resection, including those who achieved negative margins following additional resection. In this study, resection margins are defined as the proximal bile duct margin, distal bile duct margin, hepatic transection margin, and radial (dissection) margin. A positive margin is defined as the presence of invasive carcinoma, carcinoma in situ, or high-grade dysplasia within 1 mm of the resection margin. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Patients with adequate major organ function. Patients who are able to tolerate oral intake. Patients who can initiate the study treatment within 8 weeks after surgery and meet the laboratory eligibility criteria based on blood tests performed within 14 days prior to enrollment. Patients aged 18 years or older who have sufficient decision-making capacity to provide informed consent for participation in this study. Key exclusion criteria - Patients with pulmonary fibrosis or interstitial pneumonia. Patients with distant metastases at the initiation of adjuvant therapy. Patients who are unable to tolerate chemotherapy or chemoradiotherapy. Patients with active synchronous or metachronous malignancies. Patients with active infections. Patients receiving flucytosine, phenytoin, or warfarin. Patients who are pregnant or possibly pregnant. Patients deemed unsuitable for safe participation in this study by the treating physician. Target Size - 28

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 21 Day Anticipated trial start date - 2026 Year 11 Month 01 Day Last follow-up date - 2031 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072540

Disclaimer: Curated by HT Syndication.