Intraoperative Radiation Therapy for Resectable Pancreatic Cancer

Yona Cho

Status

Active, not recruiting

Conditions

Resectable Pancreatic Cancer

Treatments

Radiation: intraoperative radiotherapy, IORT

Study type

Interventional

Funder types

Other

Identifiers

NCT05181488

3-2020-0038

Details and patient eligibility

About

This phase II study is designed to investigate the efficacy of intraoperative radiotherapy after neoadjuvant chemotherapy in patients with resectable pancreatic cancer. The purpose of the study is to show the local recurrence rate after neoadjuvant chemotherapy and IORT is superior to that of surgical resection alone from the historical control. A total of 80 patients will be enrolled, and these patients will receive IORT of 10 Gy at 5 millimeter depth of the tumor bed, following neoadjuvant chemotherapy.

Enrollment

80 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically diagnosed with adenocarcinoma of the pancreas or clinically diagnosed with imaging examinations or tumor markers
20 years or older
Performance status 0-2 based on Eastern Cooperative Oncology Group (ECOG)
Patients with surgically resectable or borderline resectable and advanced pancreatic cancer that can be resected after neoadjuvant chemotherapy
Patients who voluntarily decided to participate in this clinical study and signed a written informed consent

Exclusion criteria

History of previous abdominal irradiation.
When the treatment area is not included in the appropriate radiation field according to the judgment of the radiation oncologist or Durgeon
Distant metastasis
Other systemic conditions that, under the judgment of the attending physician, would be difficult to undergo surgery or radiiotherapy