A Phase 2/3 interventional study of 5-FU and Oxaliplatine in Pancreatic Cancer, sponsored by Oslo University Hospital. Active, not recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Oslo University Hospital · Phase 2/3, Interventional, and Treatment
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
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).
3,310 studies on the registry are indexed under Pancreatic Neoplasms; 910 are open to participants now.
This study's planned enrollment of 140 is above the median of 46 across 2,480 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Oslo University Hospital is the lead sponsor of 830 studies on the registry; 146 are open to participants now.
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Exclusion Criteria:
Surgery and then postoperative adjuvant chemotherapy
Procedure: Pancreatic surgery · Drug: 5-FU · Drug: Oxaliplatine · Drug: Irinotecan
Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy
Drug: 5-FU · Drug: Oxaliplatine · Drug: Irinotecan · Procedure: Pancreatic surgery
Neoadjuvant treatment
Neoadjuvant treatment
Neoadjuvant treatment
All patients
Adjuvant treatment
Adjuvant treatment
Adjuvant treatment
Overall survival 18 month after randomization
Overall survival at 18 months after date of randomization (intention to treat)
Time frame: 18 month
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
Time frame: 1 year
Disease-free survival
Patient will come to regular after surgery for follow-up visits regarding their disease.
Time frame: until 5 years after surgery
Histopathological response
The histopathological response of the tumor to the neoadjuvant treatment will be assessed by established scores (R0 resection and (y)pN0 disease)
Time frame: Arm 1: Baseline and Arm 2; 4 weeks after baseline
Complication rate after surgery
Complication rate after surgery as measured by Dindo-Clavien/ISPGS classification systems
Time frame: 30 and 90 days
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
Time frame: Baseline
Health related Quality of Life
Data of quality of life will be assessed by the questionnaires EORTC QLQ-30
Time frame: until 5 years after surgery
Health economics
Data of quality of life will be assessed by the questionnaires EQ-5D
Time frame: until 5 years after surgery
Plan to share: No
This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Fluorouracil · Oxaliplatin · Irinotecan