orPACT-1

Phase 1

Conditions: Resectable pancreatic cancer
MedDRA version: 20.0Level: LLTClassification code 10007071Term: Cancer of head of pancreasSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-001635-21-SE

Lead Sponsor: Swedish studygroup for pancreatic cancer (SSPAC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 126

Inclusion Criteria

•Resectable tumour of the pancreatic head radiologically strongly suspect of pancreatic adenocarcinoma
•T1-3, Nx, M0 (UICC 7th version, 2010)
•age > 18 year and considered fit for major surgery
•written informed consent
•considered able to receive the study specific chemotherapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 126
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

Exclusion Criteria

Matstatic disease
Non-resectable primary pancreatic cancer

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall survival at 18 months after date of randomization (intention to treat);Secondary Objective: Disease free survival (DFS)<br>Number of positive lymph nodes in surgical specimen<br>Resection margin (R0);Primary end point(s): Overall survival at 18 months after date of randomization (intention to treat);Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection<br>•overall survival in per protocol population<br>•overall survival following resection<br>•overall survival after date of randomization (intention to treat)<br>•overall survival after 3 and 5 years<br>•disease-free survival <br>•histopathological response (R0 resection and (y)pN0 disease)<br>•complication rates after surgery (30 and 90 days, Dindo-Clavien and ISPGS classification systems)<br>•feasibility of neoadjuvant and adjuvant chemotherapy (Common Terminology Criteria for Adverse Events, grade 3-5, dose reduction, dose delay)<br>•completion rates of all parts of multimodal treatment<br>•QoL (EORTC QLQ-30)<br>•performance status (ECOG)<br>•health economics<br>•exploratory translational research<br>;Timepoint(s) of evaluation of this end point: 3-5 years