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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001635-21 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| Haukeland University Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Sahlgrenska University Hospital |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery and then postoperative adjuvant chemotherapy | Active Comparator | Surgery and then postoperative adjuvant chemotherapy |
|
| Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy | Experimental | Neoadjuvant chemotherapy, surgery, adjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-FU | Drug | Neoadjuvant treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival 18 month after randomization | Overall survival at 18 months after date of randomization (intention to treat) | 18 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disease-free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Knut Jorgen Labori, MD PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | Denmark | ||||
| Helsinki University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38237621 | Result | Labori KJ, Bratlie SO, Andersson B, Angelsen JH, Biorserud C, Bjornsson B, Bringeland EA, Elander N, Garresori H, Gronbech JE, Haux J, Hemmingsson O, Liljefors MG, Myklebust TA, Nymo LS, Peltola K, Pfeiffer P, Sallinen V, Sandstrom P, Sparrelid E, Stenvold H, Soreide K, Tingstedt B, Verbeke C, Ohlund D, Klint L, Dueland S, Lassen K; Nordic Pancreatic Cancer Trial-1 study group. Neoadjuvant FOLFIRINOX versus upfront surgery for resectable pancreatic head cancer (NORPACT-1): a multicentre, randomised, phase 2 trial. Lancet Gastroenterol Hepatol. 2024 Mar;9(3):205-217. doi: 10.1016/S2468-1253(23)00405-3. Epub 2024 Jan 15. | |
| 28841916 |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000077150 | Oxaliplatin |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| OTHER |
| Karolinska University Hospital | OTHER |
| University Hospital, Linkoeping | OTHER |
| Lund University Hospital | OTHER |
| Odense University Hospital | OTHER |
| Helsinki University Hospital, Finland | UNKNOWN |
| Norrlands University Hospital | OTHER |
| Helse Stavanger HF | OTHER_GOV |
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| Oxaliplatine |
| Drug |
Neoadjuvant treatment |
|
| Irinotecan | Drug | Neoadjuvant treatment |
|
| Pancreatic surgery | Procedure | All patients |
|
| 5-FU | Drug | Adjuvant treatment |
|
| Oxaliplatine | Drug | Adjuvant treatment |
|
| Irinotecan | Drug | Adjuvant treatment |
|
Patient will come to regular after surgery for follow-up visits regarding their disease.
| 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) | 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 | 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 | Baseline |
| Health related Quality of Life | Data of quality of life will be assessed by the questionnaires EORTC QLQ-30 | until 5 years after surgery |
| Health economics | Data of quality of life will be assessed by the questionnaires EQ-5D | until 5 years after surgery |
| Helsinki |
| 00029 |
| Finland |
| Oslo University Hospital | Oslo | Oslo | N- 0424 | Norway |
| Haukeland University Hospital | Bergen | 5021 | Norway |
| Stavanger University Hospital | Stavanger | 4011 | Norway |
| Tromsø University Hospital | Stavanger | 9038 | Norway |
| St. Olav University Hospital | Trondheim | 7030 | Norway |
| Sahlgrenska University Hospital | Gothenburg | 41345 | Sweden |
| Karolinska University Hospital | Huddinge | 14157 | Sweden |
| Linköping University Hospital | Linköping | 58185 | Sweden |
| Skåne University Hospital | Lund | Sweden |
| University Hospital of Umeå | Umeå | 90737 | Sweden |
| Uppsala University Hospital | Uppsala | 75185 | Sweden |
| Derived |
| Labori KJ, Lassen K, Hoem D, Gronbech JE, Soreide JA, Mortensen K, Smaaland R, Sorbye H, Verbeke C, Dueland S. Neoadjuvant chemotherapy versus surgery first for resectable pancreatic cancer (Norwegian Pancreatic Cancer Trial - 1 (NorPACT-1)) - study protocol for a national multicentre randomized controlled trial. BMC Surg. 2017 Aug 25;17(1):94. doi: 10.1186/s12893-017-0291-1. |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D002166 | Camptothecin |
| D000470 | Alkaloids |