Symptoms and General Pathology

All Conditions

Hypoxia

All Drugs and Chemicals

Micronutrients

Mineral

Fluorodeoxyglucose F18

Copper

Radiopharmaceuticals

Trace Elements

Copper Supplement

3 fractions of 12 Gy Relative Biological Effectiveness (RBE)

Partial radiotherapy targeting the hypoxic tumor segment

Particle radiotherapy

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

Magnetic resonance imaging

Computertomography

For the definition of the hypoxic tumor segment in treatment planning.

Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT)

For follow-up radiological tumor assessment.

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

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

Blood sampling

Slavisa Tubin, M.D.

Eugen B. Hug, Univ. Prof.

This study uses a novel, recently developed unconventional radiotherapy technique which consists of three high-dose fractions directed to special segments of unresectable bulky tumors.

This is a mono-centric, prospective, two-arms, feasibility study in which the investigator will enroll up to 22 patients with locally advanced or metastatic cancers with at least one bulky (≥6cm) lesion. This study uses a novel, recently developed unconventional radiotherapy technique, consisting of a short course (3 fractions) high dose partial irradiation targeting exclusively the hypoxic segment of unresectable bulky tumors while sparing the peritumoral immune microenvironment for induction of immune-mediated tumoricidal bystander and abscopal effects.

The present study will explore the potential biological and physical advantages of particle-based radiotherapy to deliver a highly conformal radiation dose to the hypoxic tumor segment defined by using hypoxia-specific Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM PET-CT) and dynamic contrast enhanced Magnetic Resonance Tomography imaging. Based on tumor location, volume and risk factors related to nearby organs at risk, patients will be divided in the "high-dose" or "reduced-dose" group which will be treated with different dose-schedules according to risk factors.

Additionally, radiotherapy will be administered at the precise timing, determined individually for each patient, based on the serially mapped homeostatic immune fluctuations by monitoring blood levels of the inflammatory markers. The objective is to synchronize the radiation treatment with the favorable, most reactive anti-tumor immune response phase, in order to break tumor´s immune-tolerance locally and systemically.

Particle-based Partial Tumor Irradiation of Unresectable Bulky Tumors

Particle-based Partial Tumor Irradiation Targeting Hypoxic Segment and Sparing the Peritumoral Immune Microenvironment for Unresectable Bulky Tumors

Bystander (local, at the level of the partially treated bulky tumor) response rate defined as at least a 30% regression of the unirradiated tumor tissue.

Feasibility of patient recruitment, treatment and follow-up rates.

Defined as the time from treatment until the time of death from any cause.

Defined as the time from treatment until the time of local disease progression.

Defined as the time from treatment until the time of distant disease progression.

Defined as the proportion of metastatic patients that exhibited an abscopal effect versus the total number of metastatic patients allocated to the treatment.

Proportion of patients who will achieve a partial or complete relief at different time-points.

Toxicity assessment according to NCI CTCAE v5.0

The feasibility of PARTICLE-PATHY and to it related TIMING will be defined by the proportion of patients allocated to this treatment who received it within dosimetric constraints after being able to define the immune-cycle periodicity and to synchronize radiotherapy with it versus the total number of patients allocated to the treatment.

Two key cytokines, Interleukin-2 (IL-2) and Interferon Gamma (INFg), will be serially assessed at baseline and after each radiotherapy treatment, in order to determine their potential role in modulating the immune response in relation to the bystander/abscopal effects.

Medical University of Vienna

Landesklinkum Wiener Neustadt

Klinik Ottakring

EBG MedAustron GmbH

Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

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).

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-therapy using protons or carbon ions

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

Piero Fossati, M.D.

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

This is an interventional, open label, trial of definitive hypofractionated radiotherapy for patients with locally advanced pancreatic cancer.

Within this study radiotherapy shall be delivered with active scanning particle-therapy using proton- or carbon ions radiotherapy.

Particle therapy will be performed with a simultaneous integrated boost (SIB) treating a larger target volume, including elective lymph node stations and neural plexus, at a lower dose and boosting macroscopic disease.

The investigator will explore the efficacy of these treatment in a real world scenario in which patients are allowed to receive standard systemic treatment and standard surgical treatment (if conversion to resectability is achieved).

However, and in order to record and to gain better understanding of the influence of systemic therapies on the outcomes parameters of this study, patients will be sub-stratified in 3 groups: i) patients receiving FOLFIRINOX, ii) patients receiving Gemcitabine + Nanoparticle Albumin Bound Paclitaxel (NAB-Paclitaxel), iii) patients receiving other systemic therapies or not receiving antineoplastic systemic therapy.

Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

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

Rate of locoregional tumor control at two year will be evaluated radiologically.

This endpoint will be measured with the actuarial approach.

This endpoint will be measured with the actuarial approach. It will be assessed as the union of locoregional control and survival. Patient with loco regional recurrence will be considered failures. Deceased patient will also be considered failures. Patient lost to follow-up without evidence of locoregional recurrence will be censored. Distant metastasis and peritoneal carcinosis will be irrelevant respect to this endpoint.

This endpoint will be measured with the actuarial approach. All deaths will be considered failures, patient lost to follow-up will be censored.

This endpoint will be scored as gross rate. The investigator will measure the number of patients experiencing at least one toxicity \>= Grade 4 and \>= Grade 5 and the number of events \>= Grade 4 and \>= Grade 5. The crude number will be divided by the total number of patients treated.

Quality of life will be measured with Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) before radiation therapy and at each follow-up. The FACT-Hep has 27 (+ a subscale with 18 additional) questions, each of which is answered using a 5-point Likert scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state, leading to some items being reverse-scored. Questions measure the respondents' health state over the last 7 days in four subscales: Physical Well-Being (7 questions), Social/Family Well-Being (7 questions), Emotional Well-Being (6 questions), and Functional Well-being (7 questions). This disease-specific version of the FACT-Hep contain these four core subscales, with additional (18) questions appended to address disease-specific factors.

The higher the score the better the Quality of Life.

Quality of life will be measured with EORTC Quality of Life Questionnaire-C30 before radiation therapy and at each follow-up.

Questionnaire developed to assess the quality of life of cancer patients. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Quality of life will be measured with Brief Pain Inventory before radiation therapy and at each follow-up.

The Brief Pain Inventory (BPI) is a measurement tool for assessing clinical pain.The interference items were now presented with 0-10 scales, with 0=no interference and 10=interferes completely.

The number of events, their grade and their time course will be measured.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Particle-based Partial Tumor Irradiation of Unresectable Bulky Tumors	NCT04875871	Cancer	Particle radiot... Magnetic resona... Computertomogra... Copper-64-Diace... 18-F-FluorDesox... Blood sampling	18 Years -	EBG MedAustron GmbH
Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)	NCT05191940	Pancreas Cancer	Particle-therap... Blood sampling Magnetic resona... Computertomogra... 18-F-FluorDesox...	18 Years -	EBG MedAustron GmbH
Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)	NCT05191940	Pancreas Cancer	Particle-therap... Blood sampling Magnetic resona... Computertomogra... 18-F-FluorDesox...	18 Years -	EBG MedAustron GmbH
Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)	NCT05191940	Pancreas Cancer	Particle-therap... Blood sampling Magnetic resona... Computertomogra... 18-F-FluorDesox...	18 Years -	EBG MedAustron GmbH

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