ANZCTR - Registration

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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

3/11/2024

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]

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

Condition category

Condition code

Cancer

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Proportion of participants receiving at least 80% of planned doses of neoadjuvant therapy, assessed by accessing patient electronic medical record.

Timepoint [1]

At completion of neo-adjuvant treatment (at 3 months post enrolment) and prior to assessing suitability for surgery

Secondary outcome [1]

Proportion of patients who missed surgery due to significant treatment related adverse events, assessed by review of patient medical records.

Timepoint [1]

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]

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]

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?

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

Active, not recruiting

Date of first participant enrolment

Anticipated

29/07/2022

Actual

30/08/2022

Date of last participant enrolment

Anticipated

30/06/2024

Actual

26/06/2024

Date of last data collection

Anticipated

30/06/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,VIC

Recruitment hospital [1]

Wollongong Hospital - Wollongong

Recruitment hospital [2]

Warringal Private Hospital - Heidelberg

Recruitment hospital [3]

GenesisCare - St Leonards - St Leonards

Recruitment postcode(s) [1]

2500 - Wollongong

Recruitment postcode(s) [2]

3084 - Heidelberg

Recruitment postcode(s) [3]

2065 - St Leonards

Funding & Sponsors

Funding source category [1]

Other Collaborative groups

Name [1]

Australasian Gastro-Intestinal Trials Group (AGITG)

Address [1]

GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Joint University of Wollongong and Illawarra Shoalhaven Local Health District Health and Medical Human Research Ethics Committee.

Ethics committee address [1]

Research Services Office
Level 1, Building 20
Northfields Avenue
Wollongong  NSW  2522

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/10/2021

Approval date [1]

24/01/2022

Ethics approval number [1]

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

Prof Lorraine Chantrill

Address

Head of Department Medical Oncology
Illawarra Shoalhaven Local Health District
L3 Illawarra Cancer Care Centre, Wollongong Hospital
New Dapto Rd, Wollongong NSW 2500

Country

Australia

Phone

+61 2 4222 5260

Fax

lorraine.chantrill@health.nsw.gov.au

Contact person for public queries

Name

Tina Cavicchiolo

Address

Walter and Eliza Hall Institute of Medical Research
Gibbs Lab - Personalised Oncology Division
1G Royal Parade, Parkville, VIC 3052

Country

Australia

Phone

+61 3 9345 2880

Fax

NEO-IMPACT@mh.org.au

Contact person for scientific queries

Name

Lorraine Chantrill

Address

Head of Department Medical Oncology
Illawarra Shoalhaven Local Health District
L3 Illawarra Cancer Care Centre, Wollongong Hospital
New Dapto Rd, Wollongong NSW 2500

Country

Australia

Phone

+61 2 4222 5260

Fax

lorraine.chantrill@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	1683TiP Trial in progress: NEO-adjuvant chemo-IMmunotherapy in PAnCreaTic cancer-NEO-IMPACT.	2023	https://dx.doi.org/10.1016/j.annonc.2023.09.2630
Dimensions AI	1684TiP PARPiPANC: A multicentric, single arm, phase II assessing niraparib as first line therapy for patients with metastatic homologous repair-deficient pancreatic cancer	2023	https://doi.org/10.1016/j.annonc.2023.09.2631
Dimensions AI	1685TiP Perioperative or adjuvant mFOLFIRINOX for resectable pancreatic cancer (PREOPANC-3): A multicenter randomized controlled trial	2023	https://doi.org/10.1016/j.annonc.2023.09.2632

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically