Clinical trial NCT03443921: Divestment for Artery-involved Pancreatic Cancer
Official title: Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Cancer
Locally Advanced Pancreatic Cancer
Neoadjuvant Therapy
Borderline Resectable Pancreatic Cancer
Keywords: Artery Divestment Technique
Locally Advanced Pancreatic Cancer
Neoadjuvant Therapy
Borderline Resectable Pancreatic Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT\&MRI scan and tumor markers;
2. Age \> 18 year and \<80 year;
3. Agree to participate in the study with signed informed consent.

Exclusion Criteria:

1. Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
2. Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
3. Focal vessel narrowing or contour irregularity revealed by radiology examinations;
4. Economic situations cannot afford designed treatment.

Primary outcomes:
measure: Overall mortality at one year after randomization;
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival rate after 2 years from randomization;
timeFrame: 2 years
measure: Overall survival rate after 3 years from randomization;
timeFrame: 3 years
measure: Median survival
timeFrame: 3 years
measure: Disease-free survival
timeFrame: 3 years
measure: Margin status of subjects receiving curative surgery
timeFrame: 1 years
measure: Intra-operative blood transfusion
timeFrame: 1 years
measure: Intra-operative blood loss
timeFrame: 1 years
measure: Overall surgical complication rate
timeFrame: 1 years
measure: Incidence of post-operative pancreatic fistula
timeFrame: 1 years
measure: Incidence of delayed gastric emptying
timeFrame: 1 years
measure: Incidence of post-operative hemorrhage
timeFrame: 1 years
measure: Incidence of surgical site infection
timeFrame: 1 years
measure: Incidence of other surgical complications
timeFrame: 1 years
measure: Severe adverse events rate
timeFrame: 3 years
measure: Quality of life at 0.5 year after randomization
timeFrame: 0.5 year
measure: Quality of life at 1 year after randomization
timeFrame: 1 year
measure: Quality of life at 2 years after randomization
timeFrame: 2 years
measure: Quality of life at 3 years after randomization
timeFrame: 3 years
measure: Performance status at 0.5 year after randomization
timeFrame: 0.5 year
measure: Performance status at 1 year after randomization
timeFrame: 1 year
measure: Performance status at 2 years after randomization
timeFrame: 2 years
measure: Performance status at 3 years after randomization
timeFrame: 3 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
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