Divestment for Artery-involved Pancreatic Cancer
- Conditions
- Pancreatic CancerLocally Advanced Pancreatic CancerNeoadjuvant TherapyBorderline Resectable Pancreatic Cancer
- Interventions
- Procedure: Artery Divestment Technique
- Registration Number
- NCT03443921
- Brief Summary
Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.
Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 122
- Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT&MRI scan and tumor markers;
- Age > 18 year and <80 year;
- Agree to participate in the study with signed informed consent.
- Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
- Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
- Focal vessel narrowing or contour irregularity revealed by radiology examinations;
- Economic situations cannot afford designed treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgery Group Artery Divestment Technique In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. NeoChemo Group Nab-paclitaxel In NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
- Primary Outcome Measures
Name Time Method Overall mortality at one year after randomization; 1 year
- Secondary Outcome Measures
Name Time Method Performance status at 2 years after randomization 2 years Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Performance status at 3 years after randomization 3 years Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Incidence of post-operative hemorrhage 1 years Post-operative hemorrhage (POH) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of POH of surgical cases in both group will be reported.
Quality of life at 1 year after randomization 1 year EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Incidence of surgical site infection 1 years Surgical site infection was assessed as US CDC guidelines.Incidence of surgical site infection of surgical cases in both group will be reported.
Margin status of subjects receiving curative surgery 1 years The margin status will be reported as R0, R1 and R2 according to AJCC Cancer Staging Manual 8th ed.
Intra-operative blood transfusion 1 years For both Surgery Group and participants who received operations in NeoChemo Group, category and volume of intra-operative blood transfusion will be reported.
Quality of life at 2 years after randomization 2 years EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Incidence of other surgical complications 1 years Any other undesirable situations that considered complicated with surgery will be recorded. Incidence of other surgical complications of surgical cases in both group will be reported.
Quality of life at 3 years after randomization 3 years EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Overall survival rate after 2 years from randomization; 2 years Overall survival rate after 3 years from randomization; 3 years Median survival 3 years Disease-free survival 3 years Intra-operative blood loss 1 years For both Surgery Group and participants who received operations in NeoChemo Group, intra-operative blood loss will be measured and reported by milliliter.
Overall surgical complication rate 1 years Overall surgical complication rate for both Surgery Group and participants who received operations in NeoChemo Group will be reported. Post-operative pancreatic fistula, delayed gastric emptying, post-operative hemorrhage, Surgical site infection and other surgical complications will be recorded. Percentage that candidates suffered from surgical complications of surgical cases for both group will be reported.
Incidence of post-operative pancreatic fistula 1 years Post-operative pancreatic fistula (POPF) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of post-operative pancreatic fistula of surgical cases in both group will be reported.
Incidence of delayed gastric emptying 1 years Delayed gastric emptying (DGE) will be accessed byInternational Study Group of Pancreatic Surgery (ISGPS) standards; Incidence of DGE of surgical cases in both group will be reported.
Performance status at 0.5 year after randomization 0.5 year Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Severe adverse events rate 3 years Feasibility of chemotherapy will be evaluated according to Common Terminology Criteria for Adverse Events, US NCI. Participants receiving neo-adjuvant, adjuvant or palliative chemotherapy will be accessed. Grade 3-5 adverse events, dose reduction or dose delay will be reported.
Quality of life at 0.5 year after randomization 0.5 year EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Performance status at 1 year after randomization 1 year Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Trial Locations
- Locations (1)
The First Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China