Phase II clinical trial to examine the efficacy and safety of stereotactic radiotherapy including subclinical regions for pancreatic cancer

UMIN ID: UMIN000054424

Registered date:18/05/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 2024/06/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Stereotactic radiotherapy

Outcome(s)

• Primary Outcome: 1-year locoregional control
• Secondary Outcome: Overall survival, Progression-free survival, Distant metastasis-free survival, the acute and late toxicities, the rate of conversion surgery, Disease control rate. Tumor marker kinetics

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: (1) A metallic stent has been inserted in the bile duct and duodenum. (2) Peritoneal dissemination has been confirmed by peritoneal cytology within 4 weeks prior to enrollment. (3) Cases with severe complication such as heart disease, renal disease, and hepatic disease (4) An infectious disease (excluding viral hepatitis) that requires systemic treatment (5) Other active malignancy at the start of our study (6) Patients requiring systemic steroids medication or other immunosuppressants (7) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy (8) Cases with severe psychological disorder (9) Other cases that were judged to be inappropriate for conducting this study

Related Information

• Primary Sponsor: Tohoku University
• Source(s) of Monetary Support: Tohoku University Graduate School of Medicine