A phase I/II clinical trial to verify safety and efficacy of surgical resection after carbon ion radiotherapy combined with chemotherapy for borderline resectable (BR-A) and unresectable locally advanced (UR-LA) pancreatic cancer

Shirabe Ken0 sites28 target enrollmentSeptember 8, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Shirabe Ken

•1\) Histologically or cytologically diagnosed adenocarcinoma, or clinically diagnosed pancreatic cancer by both imaging and tumor markers
•2\) No distant metastasis was observed at the time of registration, and the primary tumor was diagnosed as borderline resectable (BR\-A) or unresectable locally advanced (UR\-LA) (Pancreatic cancer treatment regulations 7th edition )
•3\) Patients aged 20 years or older at enrollment
•4\) Patients with PS 0\-1
•5\) CTCAE grade 2 if induction chemotherapy (BR: 2 or more courses, UR\-LA: 4 or more courses) is performed for the primary disease and there is no obvious tumor progression after the start of treatment, or if serious adverse events are observed recovering to
•6\) Patients with preserved major organ functions (bone marrow, liver, kidney, lung, etc.)
•(a) White blood cells: 12,000 /mm3
•(b) Neutrophils: more than or equal to 1,500 /mm3
•(c) Hemoglobin level: more than or equal to 9\.0 g/dL
•(d) Platelets: more than or equal to 100,000 /mm3

•1\) Patients with previous treatment (radiation therapy, chemotherapy, immunotherapy, etc.) other than the prescribed chemotherapy for the primary disease
•2\) Patients with distant metastases
•3\) Patients after primary tumor resection
•4\) Patients contraindicated for administration of S\-1
•5\) Patients with obvious infection or inflammation at the time of study enrollment (such as patients with a fever of 38\.0 degree or higher)
•6\) Patients with serious complications (requiring hospitalization) (cardiac disease, intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, difficult\-to\-control diabetes, renal failure, liver cirrhosis, etc.)
•7\) Patients with refractory ascites or pleural effusion
•8\) Patients with gastrointestinal fresh bleeding requiring repeated transfusions
•9\) Patients with diarrhea (more than 4 times a day or watery stools)
•10\) Patients with active double cancer at enrollment