Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

Recruiting now · Not applicable

Conditions studied: Pancreas Cancer

In brief

This is an interventional, single-arm, open-label study with high dose short course radiotherapy for patients with locally advanced pancreatic cancer.

Key facts

Study ID

NCT05191940

Run by

EBG MedAustron GmbH

People needed

30

Starts

2022-05-16

Expected to finish

2028-12-01

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has histologically or cytological confirmed diagnosis of pancreatic cancer (cases with radiological findings suspicious of pancreatic cancer AND elevated CA 19-9 may be enrolled even without positive cytology)
• The patient is not candidate for radical surgical resection because of one or more of the following reasons:
• the patient is staged as locally advanced and with unresectable disease according to the international consensus definition. Specific criteria are: there is involvement of portal vein/superior mesenteric vein with bilateral narrowing/occlusion, exceeding the inferior border of the duodenum; or tumor contact/invasion of 180 or more degree of the superior mesenteric artery or of the truncus coeliacus; or tumor contact/invasion of the proper hepatic artery/ celiac artery; or tumor contact or invasion of the aorta.
• the patient is not a candidate for radical surgery because of radiographic or biochemical (CA 19-9) progression during neoadjuvant chemotherapy despite being initially classified as resectable or borderline resectable according to the international consensus definition.
• the patient is not candidate for radical surgery because of cN+ stage
• The patient is not candidate to (further) neoadjuvant chemotherapy because of one or more of the following reasons:
• the patient is not fit for chemotherapy
• the patient has progressed under chemotherapy
• the patient has received neoadjuvant chemotherapy but is judged still not a candidate for explorative surgery.
• Negative staging for distant metastasis
• Age > 18 years
• Karnofsky index ≥ 70
• No tumor infiltration of stomach or duodenum
• The patient is informed of the diagnosis and is able to give informed consent (Ability of patient to understand character and individual consequences of the study protocol)
• Women of fertile age must have adequate conception prevention measures and must not breast feed
• Signed Informed Consent (must be available before study inclusion)

You may not qualify if…

• Non-exocrine tumors
• Major medical or psychiatric comorbidities that contraindicate radiotherapy
• Presence of distant metastasis
• Pregnancy or unwilling to do adequate conception prevention
• Lactating and unwilling to discontinue lactation
• Men of procreative potential not willing to use effective means of contraception
• Metallic prosthesis or other conditions - IF it prevents an adequate imaging for target volume definition or treatment planning at the discretion of the treating institution contraindicate radiotherapy e.g. active infections in the area
• Previous abdominal radiotherapy
• Severe hepatic or renal impairment at discretion of treating institution
• Patient refusal

Where it is running

• EBG MedAustron GmbH — Wiener Neustadt, Lower Austria, Austria (enrolling)

Full record on ClinicalTrials.gov

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