Phase II Trial of Hypo-fractionated Highly Conformal Radiotherapy for Locally Advanced Pancreatic Carcinomas

Trial ID: NCT05191940

Interventional - Phase Unknown - Recruiting

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

Conditions

• Pancreas Cancer

Interventions

• Particle-therapy using protons or carbon ions
• Blood sampling
• Magnetic resonance imaging
• Computertomography
• 18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)

Eligibility

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

Sponsor

EBG MedAustron GmbH

Source: ClinicalTrials.gov

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