Nordic Pancreatic Cancer Trial (NorPACT) - 1

Pancreatic Cancer Clinical Trial

Official title:

Nordic Multicentre Un-blinded Phase II Randomized Controlled Trial (RCT) Evaluating the Additional Efficacy of Adding Chemotherapy Prior to Resection of a Pancreatic Head Malignancy to Avoid Early Mortality in Those Ultimately Resected

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02919787
• Other study ID #: NorPACT-1
• Secondary ID: 2015-001635-21
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 2016
• Est. completion date: April 30, 2026

Study information

• Verified date: February 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluate the additional effect of adding chemotherapy prior to resection of a pancreatic head malignancy. The patients will be randomized into two groups; surgery first (control group) and neoadjuvant chemotherapy (intervention). Primary endpoint is overall survival after resection

Description:

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States. Surgical resection remains the only potentially curative treatment. However, the median survival of patients undergoing pancreatic resection alone is 16-23 months. The administration of adjuvant chemotherapy leads to an improvement in overall survival. Thus, completion of multimodality treatment (MMT) is the ideal goal and standard of care for treatment of pancreatic ductal adenocarcinoma (PDAC). Currently, the surgery-first (SF) strategy is the most universally accepted approach to resectable PDAC (and is the standard of care in Norway), but the optimal sequence of surgery and chemotherapy remains unclear. The purpose of this study is to further investigate the additional efficacy of neoadjuvant chemotherapy to the standard treatment for resectable cancer of the pancreatic head (surgery followed by adjuvant chemotherapy).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. completion date: April 30, 2026
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Resectable adenocarcinoma of the pancreatic head
• T1-3, Nx, M0 (UICC 7th version, 2010)
• Cytologic or histologic confirmation of adenocarcinoma
• Age > 18 year and considered fit for major surgery
• Written informed consent
• Considered able to receive the study specific chemotherapy

Exclusion Criteria:

• Co-morbidity precluding pancreaticoduodenectomy
• Chronic neuropathy = grade 2
• WHO performance score > 2 • Granulocyte count < 1500 per cubic millimetre
• Platelet count < 100 000 per cubic millimeter
• Serum creatinine > 1.5 UNL (upper limit normal range)
• Albumin < 2,5 g/dl
• Female patients in child bearing age not using adequate contraception, pregnant or lactating women • Mental or organic disorders which could interfere with informed consent or treatments
• Other malignancy within the past 5 years, except non-melanomatous skin or non-invasive cervical cancer
• Percutaneous tumor biopsy
• Any reason why, in the opinion of the investigator, the patient should not participate
• Pregnancy
• Breastfeeding

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• 5-FU
Neoadjuvant treatment
• Oxaliplatine
Neoadjuvant treatment
• Irinotecan
Neoadjuvant treatment

Procedure:
• Pancreatic surgery
All patients

Drug:
• 5-FU
Adjuvant treatment
• Oxaliplatine
Adjuvant treatment
• Irinotecan
Adjuvant treatment

Locations

Country	Name	City	State
Denmark	Per Pfeiffer	Odense
Finland	Ville Sallinen	Helsinki
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	Stavanger University Hospital	Stavanger
Norway	Tromsø University Hospital	Stavanger
Norway	St. Olav University Hospital	Trondheim
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Karolinska University Hospital	Huddinge
Sweden	Linköping University Hospital	Linköping
Sweden	Skåne University Hospital	Lund
Sweden	University Hospital of Umeå	Umeå
Sweden	Uppsala University Hospital	Uppsala

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital, Helse Stavanger HF, St. Olavs Hospital, University Hospital of North Norway

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival 18 month after randomization	Overall survival at 18 months after date of randomization (intention to treat)	18 month
Secondary	Overall mortality at one year following commencement of allocated treatment.	Overall mortality at one year following commencement of allocated treatment (NT or SF) for those who ultimately undergo resection	1 year
Secondary	Disease-free survival	Patient will come to regular after surgery for follow-up visits regarding their disease.	until 5 years after surgery
Secondary	Histopathological response	The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)	Arm 1: Baseline and Arm 2; 4 weeks after baseline
Secondary	Complication rate after surgery	Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems	30 and 90 days
Secondary	Feasibility of neoadjuvant and adjuvant chemotherapy	The feasibility of neo-adjuvant and adjuvant chemotherapy measured by common Terminology Criteria for Adverse Events, grade 3-5, dose reduction and dose delay	Baseline
Secondary	Health related Quality of Life	Data of quality of life will be assessed by the questionnaires EORTC QLQ-30	until 5 years after surgery
Secondary	Health economics	Data of quality of life will be assessed by the questionnaires EQ-5D	until 5 years after surgery