Divestment for Artery-involved Pancreatic Cancer

February 18, 2018 updated by: Yi Miao, The First Affiliated Hospital with Nanjing Medical University

Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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.
Other Names:
  • Sub-adventitial Resection
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall mortality at one year after randomization;
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 3 years
3 years
Overall survival rate after 2 years from randomization;
Time Frame: 2 years
2 years
Overall survival rate after 3 years from randomization;
Time Frame: 3 years
3 years
Median survival
Time Frame: 3 years
3 years
Margin status of subjects receiving curative surgery
Time Frame: 1 years
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
Time Frame: 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.
1 years
Intra-operative blood loss
Time Frame: 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.
1 years
Overall surgical complication rate
Time Frame: 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.
1 years
Incidence of post-operative pancreatic fistula
Time Frame: 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.
1 years
Incidence of delayed gastric emptying
Time Frame: 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.
1 years
Incidence of post-operative hemorrhage
Time Frame: 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.
1 years
Incidence of surgical site infection
Time Frame: 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.
1 years
Incidence of other surgical complications
Time Frame: 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.
1 years
Severe adverse events rate
Time Frame: 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.
3 years
Quality of life at 0.5 year after randomization
Time Frame: 0.5 year
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
0.5 year
Quality of life at 1 year after randomization
Time Frame: 1 year
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
1 year
Quality of life at 2 years after randomization
Time Frame: 2 years
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
2 years
Quality of life at 3 years after randomization
Time Frame: 3 years
EORTC QLQ-C30 (V3.0) will be enrolled to evaluate quality of life.
3 years
Performance status at 0.5 year after randomization
Time Frame: 0.5 year
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
0.5 year
Performance status at 1 year after randomization
Time Frame: 1 year
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
1 year
Performance status at 2 years after randomization
Time Frame: 2 years
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
2 years
Performance status at 3 years after randomization
Time Frame: 3 years
Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NMU-JSPH-PC-DIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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