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Trial registered on ANZCTR


Registration number
ACTRN12622000378729
Ethics application status
Approved
Date submitted
18/02/2022
Date registered
3/03/2022
Date last updated
22/04/2024
Date data sharing statement initially provided
3/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
NEO-IMPACT: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer
Scientific title
Investigating the safety and efficacy of NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer, NEO-IMPACT.
Secondary ID [1] 306478 0
None
Universal Trial Number (UTN)
U1111-1274-6393
Trial acronym
NEO-IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic cancer 325338 0
Condition category
Condition code
Cancer 322722 322722 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination of modified FOLFIRINOX (mFOLFIRINOX) with durvalumab (MEDI4736) in patients with resectable or borderline resectable pancreatic adenocarcinoma in the neo-adjuvant setting;
Prior to surgery, eligible patients will receive 6 cycles of mFOLFIRINOX every 2 weeks given as follows:
- Oxaliplatin 85mg/m2 intravenously on day 1
- Irinotecan 150mg/m2 intravenously on day 1
- Calcium folinate (leucovorin) 50mgas an intravenous bolus
- Fluorouracil 2400mg/m2 by continuous infusion via pump over 46 hours starting on day 1
- Pegylated G-CSF 6mg by subcutaneous injection to be given on day 3 of each cycle.
Patients will also receive 3 cycles of durvalumab (MEDI4736) every 4 weeks given as follows:
- Durvalumab 1500mg intravenously on day 1, with cycle 1, day 1 durvalumab treatment coinciding with cycle 1, day 1 of mFOLFIRINOX (ie. repeated on day 1 of cycle 3 and cycle 5 of mFOLFIRINOX.
After completion of neoadjuvant therapy, all patients will be reviewed at the local multidisciplinary meeting (MDM) to determine resectability of the primary tumour.
Curative surgery should be planned to take place within 6-8 weeks following the final dose of neoadjuvant therapy, with standard preoperative assessments to determine suitability.
Adjuvant (post-surgery) chemotherapy will start within 8-12 weeks of surgery and consist of 6 cycles of mFOLFIRINOX administered in the say way as that administered prior to surgery. There will be no adjuvant durvalumab.
Intervention code [1] 322902 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330523 0
Proportion of participants receiving at least 80% of planned doses of neoadjuvant therapy, assessed by accessing patient electronic medical record.
Timepoint [1] 330523 0
At completion of neo-adjuvant treatment (at 3 months post enrolment) and prior to assessing suitability for surgery
Secondary outcome [1] 406521 0
Proportion of patients who missed surgery due to significant treatment related adverse events, assessed by review of patient medical records.
Timepoint [1] 406521 0
Every 2 weeks during neo-adjuvant treatment, at the completion of treatment (at 3 months post enrolment) and 30 to 42 days after the last dose of immunotherapy.
Secondary outcome [2] 407046 0
Treatment related adverse events (eg. immune related side effects such as lung, liver, kidney inflammation) assessed by patient review and clinical examination and review of medical records, blood test and CT scan results.
Timepoint [2] 407046 0
Every 2 weeks during neo-adjuvant treatment, at the completion of treatment (at 3 months post enrolment) and 30 to 42 days after the last dose of immunotherapy and every 12 weeks weeks after surgery or neoadjuvant chemotherapy for 12 months.

Eligibility
Key inclusion criteria
Pancreatic adenocarcinoma proven by histology or cytology that is resectable or borderline resectable.
Good performance status (ECOG 0 - 1)
Adequate kidney, liver and bone marrow function to be able to undergo immuno-chemotherapy
Body weight above 30kg
Life expectancy of at least 12 weeks
Tumour lesion on CT or MRI scan that is measurable
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Locally advanced or metastatic pancreatic adenocarcinoma.
Neuroendocrine pancreatic carcinoma.
Prior treatment for pancreatic cancer (including another clinical trial).
Complete or intermediate dihydropyrimidine dehydrogenase deficiency (DPYD deficiency)
Major surgical procedure within 28 days prior to the first dose of immuno-chemotherapy.
History of allogenic organ transplantation.
Active or prior autoimmune or inflammatory disorders such as inflammatory bowel disease (eg. colitis, Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome (granulomatosis with polyangitis, Graves disease, rheumatoid arthritis, hypophysitis, uveitis).
Uncontrolled intercurrent illness (such as ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrheoa, psychiatric illness/social situations that would limit compliance with study requirements).
History of another primary malignancy (except malignancy treated with curative intent and with no know active disease for more than 5 years, or adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease or adequately treated carcinoma insitu without evidence of disease or history of leptomeningeal carcinomatosis or history of active primary immunodeficiency).
Active infection with TB, hepatitis B or hepatitis C.
HIV positive.
Current or prior use of immunosuppressive medication within 14 days before the first dose of immunotherapy.
Receipt of live attenuated vaccine within 30 days prior to the first dose of immuno-chemotherapy.
Patients who are pregnant or breast-feeding.
Patients or partners of patients, who are of reproductive potential and are unwilling to use effective birth control from screening to 90 days after the last dose of immunotherapy.
Known allergy or hypersensitivity to any of the drugs (immuno-chemotherapy) used or their excipients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a pilot study with a feasibility endpoint.
All analyses will include all patients who received at least 1 cycle of treatment. Summary statistics will be undertaken using descriptive methods as appropriate for relevant endpoints. No interim analysis is planned.
With a sample size of 20, aiming for at least 13 patients to receive at least 80% of planned treatment dose provides over 80% power to distinguish a 65% treatment completion rate from a 30% treatment completion rate at the 5% significance level using the binomial test.
If more than 13 patients receive at least 80% of planned treatment dose, the pilot study will be considered feasible.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/07/2022
Actual
30/08/2022
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
20
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 21784 0
Wollongong Hospital - Wollongong
Recruitment hospital [2] 21785 0
Warringal Private Hospital - Heidelberg
Recruitment hospital [3] 21822 0
GenesisCare - St Leonards - St Leonards
Recruitment postcode(s) [1] 36880 0
2065 - St Leonards
Recruitment postcode(s) [2] 36840 0
2500 - Wollongong
Recruitment postcode(s) [3] 36841 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 310823 0
Other Collaborative groups
Name [1] 310823 0
Australasian Gastro-Intestinal Trials Group (AGITG)
Country [1] 310823 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Address
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 312072 0
None
Name [1] 312072 0
Address [1] 312072 0
Country [1] 312072 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310389 0
Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee.
Ethics committee address [1] 310389 0
Research Services Office
Level 1, Building 20
Northfields Avenue
Wollongong NSW 2522
Ethics committee country [1] 310389 0
Australia
Date submitted for ethics approval [1] 310389 0
11/10/2021
Approval date [1] 310389 0
24/01/2022
Ethics approval number [1] 310389 0
2021/ETH11704

Summary
Brief summary
The NEO-IMPACT study will assess the safety of combining standard chemotherapy (modified FOLFIRINOX) with immunotherapy (durvalumab) in patients with early stage pancreatic adenocarcinoma who are considered suitable for surgery.
Who is it for?
You may be eligible for this study if you are an adult aged 18 or older, you have been diagnosed with pancreatic cancer that is suitable for surgery (resectable or borderline resectable) and your kidneys, liver and bone marrow are considered healthy enough for you to take both chemotherapy and an immunotherapy drug.
Study details
All participants who choose to enrol in this study will undergo 6 treatment cycles every 2 weeks (for a total of 12 weeks) of combined immuno-chemotherapy (durvalumab with modified FOLFIRINOX).
The chemotherapy (modified FOLFIRINOX) will be administered as a day patient in hospital. It is given via an intravenous (into a vein) infusion on day 1 of each cycle. One of the chemotherapy drugs (5-FU) will be given as a continuous infusion over 46 hours via a portable pump therefore you will return to the hospital on day 3 to have this pump disconnected , The immunotherapy drug (durvalumab) will be given via an intravenous infusion on day 1 of each second cycle i.e. cycles 1, 3 and 5. At the end of the 6 treatment cycles, participants will be assessed for their suitability for surgery. After surgery all participants will then undergo an additional 6 treatment cycles of chemotherapy alone (modified FOLFIRINOX). All participants will be monitored for 12 months after their surgery, This will include a medical review, blood tests and imaging with a CT scan every 3 months.
It is hoped this research will determine if adding immunotherapy to standard chemotherapy affects how well the treatment is tolerated, and whether it will affect how much of the planned treatment can be completed (due to potential side effects). If the combined treatments are shown to be safe, they may be prescribed to future pancreatic cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117486 0
Prof Lorraine Chantrill
Address 117486 0
Head of Department Medical Oncology
Illawarra Shoalhaven Local Health District
L3 Illawarra Cancer Care Centre, Wollongong Hospital
New Dapto Rd, Wollongong NSW 2500
Country 117486 0
Australia
Phone 117486 0
+61 2 4222 5260
Fax 117486 0
Email 117486 0
lorraine.chantrill@health.nsw.gov.au
Contact person for public queries
Name 117487 0
Ms Tina Cavicchiolo
Address 117487 0
Walter and Eliza Hall Institute of Medical Research
Gibbs Lab - Personalised Oncology Division
1G Royal Parade, Parkville, VIC 3052
Country 117487 0
Australia
Phone 117487 0
+61 3 9345 2880
Fax 117487 0
Email 117487 0
NEO-IMPACT@mh.org.au
Contact person for scientific queries
Name 117488 0
Dr Lorraine Chantrill
Address 117488 0
Head of Department Medical Oncology
Illawarra Shoalhaven Local Health District
L3 Illawarra Cancer Care Centre, Wollongong Hospital
New Dapto Rd, Wollongong NSW 2500
Country 117488 0
Australia
Phone 117488 0
+61 2 4222 5260
Fax 117488 0
Email 117488 0
lorraine.chantrill@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Published data only


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Embase1683TiP Trial in progress: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer-NEO-IMPACT.2023https://dx.doi.org/10.1016/j.annonc.2023.09.2630
Dimensions AI1685TiP Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): A multicenter randomized controlled trial2023https://doi.org/10.1016/j.annonc.2023.09.2632
Dimensions AI1684TiP PARPiPANC: A multicentric, single arm, phase II assessing niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer2023https://doi.org/10.1016/j.annonc.2023.09.2631
N.B. These documents automatically identified may not have been verified by the study sponsor.