Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
- Conditions
- Pancreatic Ductal AdenocarcinomaOligometastatic Disease
- Interventions
- Procedure: Surgery
- Registration Number
- NCT06122480
- Brief Summary
Surgical Resection of Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma (PHOLIPANC). This is an interventional, open-label, non-randomised, single-arm phase II clinical trial.
Eligible patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas must have received neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days, or other clinically indicated alternative. FOLFIRINOX is not a study treatment.
- Detailed Description
In this clinical trial the investigators will enroll subjects with hepatic or pulmonary oligometastatic pancreatic ductal adenocarcinoma and perform a synchronous surgical resection. In patients with progressive disease during or after the first four cycles of neoadjuvant chemotherapy, those patients will not be eligible for study enrollment. 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 must receive 4 more cycles of neoadjuvant chemotherapy before being evaluated for eligibility for the Study Entry Screening. Patients with hepatic metastasis with tumor response or stable disease and a resectable primary tumor after the first 4 cycles can undergo explorative laparotomy and synchronous resection of the tumor and hepatic metastases, if feasible. In patients who undergo exploratory laparotomy and are deemed to have unresectable disease by the surgeon, the patients may receive 4 more cycles of neoadjuvant chemotherapy 2-4 week after surgery, before the patient will be re-evaluated for the eligibility for the Study Entry Screening. Patients with pulmonary metastasis with tumor response or stable disease and a resectable primary tumor after the first 4 cycles can undergo resection of the primary tumor followed by resection of pulmonary metastases or vice versa, if feasible.
All eligible patients with hepatic metastasis will undergo exploratory laparotomy surgery and synchronous resection of the tumor and hepatic metastases, if feasible according to the surgeon, 2-6 weeks after the last neoadjuvant chemotherapy treatment. All eligible patients with pulmonary metastasis will undergo resection of the primary tumor followed by resection of pulmonary metastases or vice versa, if feasible.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment arm liver/lung oligometastasis Surgery Eligible patients with hepatic or pulmonary oligometastatic adenocarcinoma of the pancreas must have received neoadjuvant FOLFIRINOX chemotherapy in cycles of 14 days, or other clinically indicated alternative. FOLFIRINOX is not a study treatment. Patients with pulmonary metastasis with tumor response or stable disease and a resectable primary tumor after the first 4 cycles can undergo resection of the primary tumor followed by resection of pulmonary metastases or vice versa, if feasible.Patients with hepatic metastasis with tumor response or stable disease and a resectable primary tumor can undergo explorative laparotomy and synchronous resection of the tumor and hepatic metastases, if feasible. In patients who undergo exploratory laparotomy and are deemed to have unresectable disease by the surgeon, the patient may receive 4 more cycles of neoadjuvant chemotherapy 2-4 week after surgery, before the patient will be re-evaluated for the eligibility for the Study Entry Screening.
- Primary Outcome Measures
Name Time Method 2-year overall survival will be measured for the evaluable liver and Lung oligometastasis patient cohorts, respectively, and compare to historical controls. 48 months Time-to-event data will be analyzed according to the Kaplan-Meier method (product-limit analysis). Patients who are not known to have had an event by the time of the analyses will be censored based on the last recorded date the patient was known to be event-free.
Compare the Intrametastasis effector T cell infiltration 48 months The liver oligometastasis cohort and the lung oligometastasis cohort will be compared in terms of intra-tumoral CD8+ T cells.
- Secondary Outcome Measures
Name Time Method Medium Overall Survival (OS) and Disease Free Survival 48 months Kaplan-Meier survival curves will be constructed to summarize disease free survival and overall survival, respectively.
Health-related quality of life will be assessed by the European organization for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30) 48 months Questions 1 to 28, a 4-point scale is used, ranging from 1 ("Not at all") to 4 ("Very much"), with lower scores indicating a more positive outcome. Questions 29 and 30 employ a 7-point scale, with scores ranging from 1 ("Very poor") to 7 ("Excellent"), where higher scores signify a better outcome
Perioperative morbidity and mortality as assessed by the Common terminology criteria for adverse events 48 months The safety analysis includes type, incidence, and severity of adverse events (severity according to Common terminology criteria for adverse events version 5.0).
Health-related quality of life as assessed by the European Organisation for Research and Treatment of Cancer in Pancreatic Cancer (EORTC QLQ-PAN26) 48 months European Organisation for Research and Treatment of Cancer in pancreatic cancer includes 26 questions with two subscales: functioning scales (4 questions),and symptom scales (22 questions). The functional scale, the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life. All scores are scaled to range from 0-100.
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States