Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

NCT05191940 | Recruiting

• 1 other identifier: LAPC-MA-092021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Particle Radiotherapy; Hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• Locoregional tumor control

  Rate of locoregional tumor control at two year will be evaluated radiologically. This endpoint will be measured with the actuarial approach.

  At two year

Secondary Outcomes (7)

• Loco-regional progression-free survival

  104 weeks after therapy

• Overall survival

  Maximal 109 weeks

• Incidence of CTCAE v5.0 G4-5 toxicity

  From enrollment to six months after radiation therapy initiation

• Patient reported Health-related Quality of Life, measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)

  Maximal 109 weeks

• Patient reported Health-related Quality of Life, measured with European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-C30

  Maximal 109 weeks

Study Arms (1)

Particle radiotherapy

OTHER

According to the radiation plan using protons or carbon ions (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).

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

Interventions

18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT) DIAGNOSTIC_TEST

For treatment planning as well as for follow-up radiological tumor assessment.

Particle radiotherapy

Particle-therapy using protons or carbon ions RADIATION

According to the radiation plan (between 25 and a maximum of 40 Gy). Planning Target Volume 1 : 25 Gy (Relative Biological Effectiveness) in 5 fractions of 5 Gy (Relative Biological Effectiveness) Planning Target Volume 2 : A simultaneous integrated boost (SIB) will be delivered to the Planning Target Volume 2: 40 Gy (Relative Biological Effectiveness) in 5 fractions of 8 Gy (Relative Biological Effectiveness).

Particle radiotherapy

Blood sampling DIAGNOSTIC_TEST

Evaluation before treatment-start, after treatment and follow-up period.

Particle radiotherapy

Magnetic resonance imaging DIAGNOSTIC_TEST

For treatment planning as well as for follow-up radiological tumor assessment.

Particle radiotherapy

Computertomography DIAGNOSTIC_TEST

For treatment planning as well as for follow-up radiological tumor assessment.

Particle radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• EBG MedAustron GmbH: lead

Study Sites (1)

EBG MedAustron GmbH

Wiener Neustadt, Lower Austria, 2700, Austria

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Blood Specimen Collection; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging

Study Officials

• Piero Fossati, M.D.

  EBG MedAustron GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piero Fossati, M.D.

CONTACT

+43 664 80878; piero.fossati@medaustron.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 14, 2022
• Study Start: May 16, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2025-05

Locations

AU (1)