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

Phase I clinical trial to examine the safety of stereotactic radiotherapy including subclinical regions for pancreatic cancer - Clinical trial of stereotactic radiotherapy including subclinical regions for pancreatic cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044754

Enrollment

Registered

2021-07-07

Start date

2021-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic cancer

Interventions

Stereotactic radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Borderline resectable or unresectable pancreatic cancer (with or without prior chemotherapy, with or without regional lymph node metastasis) (2) Histologically or cytologically proven adenocarcinoma (3) Maximum tumor diameter is 5 cm or less (4) No obvious invasion to gastrointestinal organs such as stomach and duodenum. (5) Aged 20 to 80 years old (6) ECOG PS of 0 or 1 (7) No previous history of surgical resection for pancreatic cancer (8) No previous history of chemotherapy or radiation therapy for abdominal malignancy (9) Adequate organ functions (10) Written informed consent

Exclusion criteria

Exclusion 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) Fever over 38 degrees Celsius (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

Design outcomes

Primary

Measure	Time frame
Frequency of acute toxicities within 14 days after the complete of stereotactic radiotherapy.	—

Secondary

Measure	Time frame
Frequency of subacute and late toxicities, Overall survival rate, Progression-free survival rate.	—

Countries

Japan

Contacts

Public ContactRei Umezawa

Tohoku University Hospital Department of Radiation Oncology

reirei513@hotmail.com022-717-7312

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026