High dose short course radiotherapy for locally advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial evaluates the efficacy of hypofractionated particle radiotherapy using protons or carbon ions for patients with locally advanced pancreatic cancer. The study employs a single-arm, open-label design, allowing patients to receive standard systemic treatments alongside the radiotherapy. Participants will be stratified based on the type of systemic therapy they receive, including FOLFIRINOX or Gemcitabine combined with NAB-Paclitaxel. The goal is to assess the treatment's effectiveness in a real-world setting and understand how systemic therapies influence outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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)
2. The patient is not candidate for radical surgical resection because of one or more of the following reasons:

   1. 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.
   2. 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.
   3. the patient is not candidate for radical surgery because of cN+ stage
3. The patient is not candidate to (further) neoadjuvant chemotherapy because of one or more of the following reasons:

   1. the patient is not fit for chemotherapy
   2. the patient has progressed under chemotherapy
   3. the patient has received neoadjuvant chemotherapy but is judged still not a candidate for explorative surgery.
4. Negative staging for distant metastasis
5. Age \> 18 years
6. Karnofsky index ≥ 70
7. No tumor infiltration of stomach or duodenum
8. 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)
9. Women of fertile age must have adequate conception prevention measures and must not breast feed
10. Signed Informed Consent (must be available before study inclusion)

Exclusion Criteria:

1. Non-exocrine tumors
2. Major medical or psychiatric comorbidities that contraindicate radiotherapy
3. Presence of distant metastasis
4. Pregnancy or unwilling to do adequate conception prevention
5. Lactating and unwilling to discontinue lactation
6. Men of procreative potential not willing to use effective means of contraception
7. 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
8. Previous abdominal radiotherapy
9. Severe hepatic or renal impairment at discretion of treating institution
10. Patient refusal

Where it's running

• EBG MedAustron GmbH
  Wiener Neustadt, Lower Austria, Austria Recruiting

Study contacts

• Principal investigator: Piero Fossati, M.D. — EBG MedAustron GmbH
• Study coordinator: Piero Fossati, M.D.
• Email: piero.fossati@medaustron.at
• Phone: +43 664 80878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.