This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group. Patients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy). If the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study. If the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care. If the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.
This is an interventional, open-label, non-randomized, single-arm clinical trial with 2 cohorts. Patients who have hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas and who receive neoadjuvant Liposomal Irinotecan Combined with Oxaliplatin and 5-Fluoracil/Folinic Acid (NALIRIFOX) chemotherapy pre-operatively are eligible. In patients with progressive disease during or after the first four cycles, patients will become ineligible. Patients with tumor response or stable disease after the first 4 cycles but a non-resectable primary tumor according to the evaluation of an interdisciplinary tumor board will receive 4 more cycles of neoadjuvant chemotherapy as per standard of care. Patients with a technically resectable primary tumor and tumor response or stable disease of their metastatic disease according to the evaluation of an interdisciplinary tumor board after the first 4 cycles will undergo exploratory laparotomy and synchronous or staged resection of the primary tumor and the hepatic or pulmonary metastases by using the standard of care surgical techniques 2-6 weeks after the last neoadjuvant chemotherapy. If the primary tumor is deemed unresectable by the surgeon during exploratory laparotomy, these patients may receive 4 more cycles of adjuvant chemotherapy as per standard of care 2-4 weeks after the exploratory laparotomy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
40
Patients with a technically resectable primary tumor and tumor response or stable disease of their metastatic disease according to the evaluation of an interdisciplinary tumor board after the first 4 cycles will undergo exploratory laparotomy and synchronous or staged resection of the primary tumor and the hepatic or pulmonary metastases by using the standard of care surgical techniques 2-6 weeks after the last neoadjuvant chemotherapy. Residual tumor classification, also known as R Classification defines how complete the resection of the malignancy has been at surgery: R0: no residual tumor/R1: microscopic residual tumor
Efficacy of R0/R1 resection
Assessed by tumor imaging
Time frame: Prior to surgery to 4-12 weeks after surgery
Safety of surgical resection of synchronous pulmonary or hepatic oligometastatic ductal adenocarcinoma
Surgical complications will be defined based on Clavien-Dindo classification and will be monitored continuously. The monitoring rule will focus on Grade IIIa surgical complication or above deemed related to the chemotherapy regimen (liposomal irinotecan, oxaliplatin, 6-fluorouracil/folinic acid) which is beyond what may be expected for chemotherapy or resection without immunotherapy.
Time frame: End of surgical procedure
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-30)
The QLQ-C30 is composed of both multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. A crucial Summary Score (0-100) combines 13 scales (excluding Global QoL \& Financial Impact), with higher scores indicating better overall quality of life. Scoring requires specific formulas from the official manual, with procedures for handling missing data and ensuring consistency across different scales, often involving reversing symptom scales for uniform interpretation.
Time frame: Prior to surgery and 4-12 weeks after surgery
European Organization for Research and Treatment of Cancer Quality of Life for pancreatic ductal adenocarcinoma (EORTC QLQ-PAN26)
Raw scores from the questionnaire items (e.g., 1=Not at all, 4=Very much) are linearly transformed to a 0-100 scale. Higher score on a symptom scale = Worse symptoms/more problems (e.g., pancreatic pain). Higher score on a functional scale = Better quality of life/functioning (e.g., planning activities)
Time frame: Prior to surgery and 4-12 weeks after surgery
Progression-free survival (PFS)
Assessment of mortality of participant continuously post surgery until study end.
Time frame: Up to 25 months after re-section of tumor
Recurrence-free survival (RFS)
Assessment of health status of participant continuously post surgery until study end.
Time frame: Up to 25 months after re-section of tumor
Overall survival
Length of time participant survives post surgical re-section.
Time frame: Up to 25 months after re-section of tumor
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