Short or long NAT for BR/LAPC (ADVANTAGE)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vastra Gotalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Neoplasms [C04]

Trial duration

19 Oct 2023 → ongoing

Decision date (initial)

2025-11-25

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Therapy

To assess the optimal duration of preoperative chemotherapy before conversion surgery for patients with borderline and locally advanced pancreatic ductal adenocarcinoma in attempt to improve survival

Secondary objectives 1

1. • Overall survival in intention-to-treat and per protocol treated • Progression-free survival • Overall survival among non-resected at 24 months • Overall survival among patients with BR in the two arms and among patients with LAPC in the two arms in ITT • Overall and progression-free survival among resected patients with BR in the two arms and among resected patients with LAPC in the two arms • Difference in overall and progression-free survival between BR and LAPC patients – in ITT among all treated patients and among resected patients • Resection rate • Dose intensity • Toxicity • Chemotherapy start-rate and completion rate • Surgical complications, 90 days (Clavien-Dindo and ISGPS) • Quality of life (EORTC QLQ-PAN26 and PACADI) • Biochemical response (CA19-9, CEA, CA125). • Histopathologic response (CAP) • N0 resection rate

Conditions and MedDRA coding

Advanced pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. • Borderline or locally advanced pancreatic adenocarcinoma at diagnosis according to NCCN Clinical Practice Guidelines, version 1.2022 • Histo- or cytologically confirmed adenocarcinoma • T1-4, Nx, M0 according to AJCC 8th edition • Age ≥ 18 years-of-age • ECOG 0-1 and considered fit for the planned chemotherapy and surgery • Written informed patient consent

Exclusion criteria 1

1. - Co-morbidity precluding pancreatic surgery or chemotherapy - Sensitivity to any of the drugs in the proposed management regimens - ECOG ≥2 - neuropathy ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), version 6 [47] - granulocyte count < 1500 per cubic millimetre (< 1,5 x 109/L) - platelet count < 100 000 per cubic millimetre (< 100 x 109/L) - serum creatinine > 1.5 UNL (upper limit normal range) - albumin <2,5 g/dl (<25 g/L) - total bilirubin >3 x ULN - ASAT (SGOT) and ALAT (SGPT) >2.5 x institutional ULN - female patients in child-bearing age not using adequate contraception, pregnant or lactating women - mental or somatic disorders which could possibly interfere with informed consent, compliance or the planned treatments - previous oncologic treatment for pancreatic adenocarcinoma within the past 5 years - Any reason according to the investigator why the patient cannot comply with the protocol or is not suitable to participate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. • Overall survival at 24 months after randomization • Overall survival among resected patients at 24 months after randomization

Secondary endpoints 1

1. • Overall survival in intention-to-treat and per protocol treated • Progression-free survival • Overall survival among non-resected at 24 months • Overall survival among patients with BR in the two arms and among patients with LAPC in the two arms in ITT • Overall and progression-free survival among resected patients with BR in the two arms and among resected patients with LAPC in the two arms • Difference in overall and progression-free survival between BR and LAPC patients – in ITT among al

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vastra Gotalandsregionen

Sponsor organisation

Vastra Gotalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vastra Gotalandsregionen

Contact name

Elena Rangelova

Public contact point

Organisation

Vastra Gotalandsregionen

Contact name

Elena Rangelova

Locations

2 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications