Divestment for Artery-involved Pancreatic Cancer

NCT03443921 | Unknown

• 1 other identifier: NMU-JSPH-PC-DIV
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Overall mortality at one year after randomization;

  1 year

Secondary Outcomes (22)

• 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

  1 years

Study Arms (2)

Surgery Group

EXPERIMENTAL

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

NeoChemo Group

ACTIVE COMPARATOR

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

Interventions

Artery Divestment Technique PROCEDURE

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

Surgery Group

Nab-paclitaxel DRUG

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.

NeoChemo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (7)

• Ryan DP, Hong TS, Bardeesy N. Pancreatic adenocarcinoma. N Engl J Med. 2014 Nov 27;371(22):2140-1. doi: 10.1056/NEJMc1412266. No abstract available.

  PMID: 25427123 BACKGROUND

• Zhang H, Wroblewski K, Jiang Y, Penney BC, Appelbaum D, Simon CA, Salgia R, Pu Y. A new PET/CT volumetric prognostic index for non-small cell lung cancer. Lung Cancer. 2015 Jul;89(1):43-9. doi: 10.1016/j.lungcan.2015.03.023. Epub 2015 Apr 9.

  PMID: 25936471 BACKGROUND

• Tang K, Lu W, Qin W, Wu Y. Neoadjuvant therapy for patients with borderline resectable pancreatic cancer: A systematic review and meta-analysis of response and resection percentages. Pancreatology. 2016 Jan-Feb;16(1):28-37. doi: 10.1016/j.pan.2015.11.007. Epub 2015 Dec 2.

  PMID: 26687001 BACKGROUND

• Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

  PMID: 28055103 BACKGROUND

• Seufferlein T, Bachet JB, Van Cutsem E, Rougier P; ESMO Guidelines Working Group. Pancreatic adenocarcinoma: ESMO-ESDO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012 Oct;23 Suppl 7:vii33-40. doi: 10.1093/annonc/mds224. No abstract available.

  PMID: 22997452 BACKGROUND

• Fortner JG, Kim DK, Cubilla A, Turnbull A, Pahnke LD, Shils ME. Regional pancreatectomy: en bloc pancreatic, portal vein and lymph node resection. Ann Surg. 1977 Jul;186(1):42-50. doi: 10.1097/00000658-197707000-00007.

  PMID: 195543 BACKGROUND

• Chua TC, Saxena A. Extended pancreaticoduodenectomy with vascular resection for pancreatic cancer: a systematic review. J Gastrointest Surg. 2010 Sep;14(9):1442-52. doi: 10.1007/s11605-009-1129-7. Epub 2010 Apr 9.

  PMID: 20379794 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Yi Miao, MD, PhD

CONTACT

+86-25-68136508; miaoyi@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pancreas Center

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: February 23, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2021
• Last Updated: February 23, 2018

Record last verified: 2018-02

Locations

CN (1)