An interventional study of Artery Divestment Technique and Nab-paclitaxel in Pancreatic Cancer, Locally Advanced Pancreatic Cancer and Neoadjuvant Therapy, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Procedure: Artery Divestment Technique
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.
Drug: Nab-paclitaxel
Tunica adventitia was pick up by forceps and opened by electrocoagulation at 1 cm distal from tumor-artery contact. Space between tunica adventitia and external elastic lamina (EEL) were blunt lifting tumor-invaded adventitia by angled clamp. Adventitia was then sectioned to show EEL. Loose dissect space could be achieve along long the plane between EEL and adventitia as long as tumor invasion outside EEL. Tumor and invaded adventitia were further cut open by electrocoagulation proximally. Circumferentially, separation could be done by blunt dissection around EEL. Nourishing blood vessels of the artery would be secured by electrocoagulation or ultrasonic scalpel while major branch would be ligated or transfixed.
Also known as: Sub-adventitial Resection
After eligibility testing as blood tests, contrast-enhanced CT and MRI scan, 3 cycles were administered (1,000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 every 28 days).Patients will be reevaluated and curative operation would be attempted if without disease progression.
Overall mortality at one year after randomization;
Time frame: 1 year
Overall survival rate after 2 years from randomization;
Time frame: 2 years
Overall survival rate after 3 years from randomization;
Time frame: 3 years
Median survival
Time frame: 3 years
Disease-free survival
Time frame: 3 years
Margin status of subjects receiving curative surgery
The margin status will be reported as R0, R1 and R2 according to AJCC Cancer Staging Manual 8th ed.
Time frame: 1 years
Intra-operative blood transfusion
For both Surgery Group and participants who received operations in NeoChemo Group, category and volume of intra-operative blood transfusion will be reported.
Time frame: 1 years
Intra-operative blood loss
For both Surgery Group and participants who received operations in NeoChemo Group, intra-operative blood loss will be measured and reported by milliliter.
Time frame: 1 years
Overall surgical complication rate
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.
Time frame: 1 years
Incidence of post-operative pancreatic fistula
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.
Time frame: 1 years
Incidence of delayed gastric emptying
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.
Time frame: 1 years
Incidence of post-operative hemorrhage
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.
Time frame: 1 years
Incidence of surgical site infection
Surgical site infection was assessed as US CDC guidelines.Incidence of surgical site infection of surgical cases in both group will be reported.
Time frame: 1 years
Incidence of other surgical complications
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.
Time frame: 1 years
Severe adverse events rate
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.
Time frame: 3 years
Quality of life at 0.5 year after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Time frame: 0.5 year
Quality of life at 1 year after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Time frame: 1 year
Quality of life at 2 years after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Time frame: 2 years
Quality of life at 3 years after randomization
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
Time frame: 3 years
Performance status at 0.5 year after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Time frame: 0.5 year
Performance status at 1 year after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Time frame: 1 year
Performance status at 2 years after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Time frame: 2 years
Performance status at 3 years after randomization
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
Time frame: 3 years
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The First Affiliated Hospital with Nanjing Medical University