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Divestment for Artery-involved Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03443921
Recruitment Status : Not yet recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Yi Miao, The First Affiliated Hospital with Nanjing Medical University

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Locally Advanced Pancreatic Cancer Neoadjuvant Therapy Borderline Resectable Pancreatic Cancer Procedure: Artery Divestment Technique Drug: Nab-paclitaxel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

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
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 Name: 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.




Primary Outcome Measures :
  1. Overall mortality at one year after randomization; [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall survival rate after 2 years from randomization; [ Time Frame: 2 years ]
  2. Overall survival rate after 3 years from randomization; [ Time Frame: 3 years ]
  3. Median survival [ Time Frame: 3 years ]
  4. Disease-free survival [ Time Frame: 3 years ]
  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Performance status at 0.5 year after randomization [ Time Frame: 0.5 year ]
    Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.

  20. Performance status at 1 year after randomization [ Time Frame: 1 year ]
    Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.

  21. Performance status at 2 years after randomization [ Time Frame: 2 years ]
    Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.

  22. Performance status at 3 years after randomization [ Time Frame: 3 years ]
    Karnofsky Performance Status Scale will be enrolled to evaluate Performance status.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443921


Contacts
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Contact: Yi Miao, MD, PhD +86-25-68136508 miaoyi@njmu.edu.cn

Locations
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China, Jiangsu
The First Affiliated Hospital of Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210029
Contact: Yi Miao, MD, PhD    +86-25-68136508    miaoyi@njmu.edu.cn   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University

Publications:
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Responsible Party: Yi Miao, Director of Pancreas Center, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03443921     History of Changes
Other Study ID Numbers: NMU-JSPH-PC-DIV
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yi Miao, The First Affiliated Hospital with Nanjing Medical University:
Artery Divestment Technique
Locally Advanced Pancreatic Cancer
Neoadjuvant Therapy
Borderline Resectable Pancreatic Cancer

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action