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Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

ConditionPancreas Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEBG MedAustron GmbH

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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

Disqualifiers

Non-exocrine tumors

Major medical or psychiatric comorbidities that contraindicate radiotherapy

Presence of distant metastasis

Pregnancy or unwilling to do adequate conception prevention

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

  • Blood sampling

    Diagnostic test

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

  • Magnetic resonance imaging

    Diagnostic test

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

  • Computertomography

    Diagnostic test

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

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Particle radiotherapyOther 5 interventions

Trial outcomes

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.

Time frame
At two year

Secondary outcomes

1

Loco-regional progression-free survival

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.

Time frame
104 weeks after therapy
2

Overall survival

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

Time frame
Maximal 109 weeks
3

Incidence of CTCAE v5.0 G4-5 toxicity

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.

Time frame
From enrollment to six months after radiation therapy initiation
4

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

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.

Time frame
Maximal 109 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

EBG MedAustron GmbH

Lead sponsor

Source ClinicalTrials.gov
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