Panc dose escalation

JRCT ID: jRCTs032210292

Registered date:02/09/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 01/03/2022
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Carbon-ion radiotherapy is performed using medical heavy particle accelerator (HIMAC) installed at QST Hospital. The irradiation field includes the tumor identified by medical imaging examinations. Position verification is performed by referring to bones. The irradiation is done once a day.

Outcome(s)

• Primary Outcome: Acute adverse reactions
• Secondary Outcome: Late adverse reactions, local control rate, overall survival period

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Histologically or clinically diagnosed primary pancreatic tumor
(2) No indication for curative resection or no desire for surgery
(3) Has evaluable disease
(4) No obvious distant metastasis
(5) Age at the time of enrollment is 20 years or older
(6) Have a performance status (EGOG) of 0-2
(7) No prior surgical resection*1 or radiation therapy for pancreatic cancer
*1: Excluding simple laparotomy, gastrojejunostomy, and bile duct jejunal anastomosis
(8) Patients who are estimated to have a chance of survival for at least 3 months
(9) Patient's written consent for participation in the study has been obtained.

Exclude criteria

(1) Tumor involvement in the mucosal surface of the gastrointestinal tract
(2) A metal stent has been inserted.
(3) Active gastroduodenal ulcer is present
(4) Active and refractory infection in the irradiated area
(5) Patient has serious complications
(6) History of radiation therapy in the area
(7) It is judged that it is difficult to carry out this study for medical, psychological, or other reasons. Other reasons that the physician deems inappropriate for enrollment in this study
(8) Adult who lacks the capacity to give consent
(9) Eligible for the clinical trial of [A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer] (jRCT1031190131)

Related Information

• Primary Sponsor: Yamada Shigeru