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Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial) (LAPC)

Primary Purpose

Pancreas Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

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)

About this trial

This is an interventional other trial for Pancreas Cancer focused on measuring Particle Radiotherapy, Hypofractionated radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
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
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.
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
Signed Informed Consent (must be available before study inclusion)

Exclusion Criteria:

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

Sites / Locations

EBG MedAustron GmbHRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Particle radiotherapy

Arm Description

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).

Outcomes

Primary Outcome Measures

Locoregional tumor control

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

Secondary Outcome Measures

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.

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.

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.

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.

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

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.

Patient reported Health-related Quality of Life, measured with Brief Pain Inventory

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.

Incidence of CTCAE v5.0 Grade 2 - Grade 5 acute, subacute and late toxicities

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

Full Information

NCT ID

NCT05191940

First Posted

December 16, 2021

Last Updated

August 25, 2022

Sponsor

EBG MedAustron GmbH

1. Study Identification

Unique Protocol Identification Number

NCT05191940

Brief Title

Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

Acronym

LAPC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 16, 2022 (Actual)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EBG MedAustron GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreas Cancer

Keywords

Particle Radiotherapy, Hypofractionated radiotherapy

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Particle radiotherapy

Arm Type

Other

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Particle-therapy using protons or carbon ions

Intervention Description

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).

Intervention Type

Diagnostic Test

Intervention Name(s)

Blood sampling

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Magnetic resonance imaging

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Computertomography

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Locoregional tumor control

Description

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 Outcome Measure Information:

Title

Loco-regional progression-free survival

Description

Time Frame

104 weeks after therapy

Title

Overall survival

Description

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

Title

Incidence of CTCAE v5.0 G4-5 toxicity

Description

Time Frame

From enrollment to six months after radiation therapy initiation

Title

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

Description

Time Frame

Maximal 109 weeks

Title

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

Description

Time Frame

Maximal 109 weeks

Title

Patient reported Health-related Quality of Life, measured with Brief Pain Inventory

Description

Time Frame

Maximal 109 weeks

Title

Incidence of CTCAE v5.0 Grade 2 - Grade 5 acute, subacute and late toxicities

Description

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

Time Frame

104 weeks after therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Signed Informed Consent (must be available before study inclusion) Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Piero Fossati, M.D.

Phone

+43 664 80878

Ext

408

piero.fossati@medaustron.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Piero Fossati, M.D.

Organizational Affiliation

EBG MedAustron GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

EBG MedAustron GmbH

City

Wiener Neustadt

State/Province

Niederösterreich

ZIP/Postal Code

2700

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piero Fossati, M.D.

Phone

+43 2622 26 100

Ext

408

piero.fossati@medaustron.at

First Name & Middle Initial & Last Name & Degree

Piero Fossati, M.D.

12. IPD Sharing Statement

Learn more about this trial

Radiotherapy for Locally Advanced Pancreatic Carcinomas (Phase II Trial)

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