Tokyo, March 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060823) titled 'Prospective Observational Study on the Indications, Efficacy, and Safety of Conversion Surgery After Non-Surgical Treatment for Locally Advanced or Metastatic Pancreatic Cancer (JG Project-01)' on March 5.

Study Type: Observational

Primary Sponsor: Institute - Cancer Institute Hospital of JFCR

Condition: Condition - Unresectable Pancreatic Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To prospectively evaluate the feasibility, safety, and efficacy of conversion surgery (CS) in patients with locally advanced pancreatic cancer (UR-LA or BR-A) and metastatic pancreatic cancer (UR-M) considered to fall within the criteria for potentially convertible disease. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients aged over 20 years at the time of informed consent. 2. Patients diagnosed with unresectable pancreatic cancer at the initial presentation, defined by major arterial involvement and/or distant metastasis. 3. Borderline resectable pancreatic cancer (BRA): Tumor contact or invasion of under 180 degrees with the celiac axis (CA) and/or common hepatic artery (CHA), and/or under 180 degrees contact with the superior mesenteric artery (SMA) without definite arterial encasement. 4. Potentially convertible pancreatic cancer, defined as follows: (a) Potentially convertible locally advanced pancreatic cancer (URLAPC): Tumor contact or invasion of 180 to 360 degrees with the celiac axis (CA) and/or common hepatic artery (CHA), and/or 180 to 360 degrees contact with the superior mesenteric artery (SMA) without definite encasement; or invasion of the portal vein (PV) deemed unreconstructable. (b) Potentially convertible metastatic pancreatic cancer (URMPC): (1) Patients meeting any of the following conditions: Up to three liver metastases (2) Metastatic involvement in up to two sites among liver metastasis, lung metastasis, and para-aortic lymph node metastasis (multiple organs allowed) (3) Positive peritoneal cytology (CY1) without macroscopic peritoneal dissemination, confirmed by staging laparoscopy. 5. Patients planned to undergo non-surgical treatment and who understand and agree to the possibility of conversion surgery (CS) thereafter. 6. Adequate organ function and general condition judged sufficient to tolerate surgical resection. 7. Written informed consent obtained from the patient after receiving a full explanation of the study and demonstrating adequate understanding. Key exclusion criteria - 1. Patients younger than 20 years of age at the time of informed consent. 2. Patients with resectable pancreatic cancer at the initial diagnosis. 3. Tumor conditions exceeding the above eligibility criteria, such as definite encasement or severe narrowing of the superior mesenteric artery (SMA) or peritoneal dissemination. 4. Patients for whom conversion surgery (CS) is not intended at the time of enrollment, or those who do not agree to the possibility of CS after non-surgical treatment. 5. Patients judged unable to tolerate surgical resection due to poor general condition. 6. Patients with recurrent pancreatic cancer. 7. Patients deemed inappropriate for participation in the study by the principal investigator for any other reason. Target Size - 100

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2020 Year 04 Month 30 Day Date of IRB - 2020 Year 06 Month 15 Day Anticipated trial start date - 2021 Year 01 Month 01 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069601

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