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2018-03
2019-03
2021-03
122
NCT03443921
The First Affiliated Hospital with Nanjing Medical University
The First Affiliated Hospital with Nanjing Medical University
INTERVENTIONAL
Divestment for Artery-involved Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-12-17 | N/A | 2018-02-18 |
2018-02-18 | N/A | 2018-02-23 |
2018-02-23 | N/A | 2018-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Surgery 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. | PROCEDURE: Artery Divestment Technique
|
| ACTIVE_COMPARATOR: NeoChemo Group 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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall mortality at one year after randomization; | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 | |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 3 years |
| Quality of life at 0.5 year after randomization | EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life. | 0.5 year |
| Quality of life at 1 year after randomization | EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life. | 1 year |
| Quality of life at 2 years after randomization | EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life. | 2 years |
| Quality of life at 3 years after randomization | EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life. | 3 years |
| Performance status at 0.5 year after randomization | Karnofsky Performance Status Scale will be enrolled to evaluate Performance status. | 0.5 year |
| Performance status at 1 year after randomization | Karnofsky Performance Status Scale will be enrolled to evaluate Performance status. | 1 year |
| Performance status at 2 years after randomization | Karnofsky Performance Status Scale will be enrolled to evaluate Performance status. | 2 years |
| Performance status at 3 years after randomization | Karnofsky Performance Status Scale will be enrolled to evaluate Performance status. | 3 years |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Yi Miao, MD, PhD Phone Number: +86-25-68136508 Email: miaoyi@njmu.edu.cn |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
