A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer

June 8, 2026 updated by: University Health Network, Toronto

A Phase I/II Study Evaluating the Feasibility and Safety of Neoadjuvant Gemcitabine/Nab-paclitaxel (GA) and Concurrent Gemcitabine and Radiation Therapy Followed By Pancreatic Resection and Major Arterial Resection for Adenocarcinoma of the Pancreas (ARCAP) in Patients With Advanced Disease

This is a phase 1 (the first phase in testing a new drug, to see how safe a new drug or new indication/population ) and phase 2 (the second phase in testing a new drug or new indication/population to see how effective the drug is) study of neoadjuvant (treatment before the main treatment) with gemcitabine and nab-paclitaxel (abraxane) and gemcitabine and radiation therapy before surgery and then gemcitabine and nab-paclitaxel after surgery in patients with pancreatic cancer that has grown to involve one of the major artery branches.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Gemcitabine and nab-paclitaxel are chemotherapy drugs that are currently approved by Health Canada for use in combination for the treatment of pancreatic cancer. However, the combination of gemcitabine and nab-paclitaxel as a neoadjuvant treatment prior to gemcitabine and radiation is experimental. Surgery to remove or reconstruct the major artery is also experimental.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Surgical:

  • Medically fit for major pancreatic surgery
  • No evidence of metastases
  • No prior resection
  • Arterial involvement limited to a single major vessel and is resectable
  • Tumour-free margins could be achieved
  • Acceptable length of vessel
  • Mass considered otherwise resectable by current standards

General:

  • Less than 70 years old
  • Performance status <=2
  • Has pancreatic adenocarcinoma
  • Adequate bone marrow and organ function
  • Therapeutic heparin is allowed
  • Taking chronic erythropoietin are permitted
  • Not pregnant
  • Agree to use contraception
  • Able to provide written consent

Exclusion Criteria:

Surgical:

  • Aortic involvement
  • Involvement of 2 major arterial trunks
  • SMV/portal venous occlusion, cannot be reconstructed
  • Extensive venous involvement, no arterial involvement
  • Disease progression on neo-adjuvant treatme

General:

  • Concurrent cancer diagnosis
  • Other malignancies unless all therapy completed, no disease for >=3 years
  • Prior radiotherapy or chemo within 1 year, to pancreas
  • Bone marrow transplant/stem cell rescue
  • Major surgery <4 wks prior
  • Distant metastases
  • Renal dysfunction
  • Pulmonary insufficiency
  • History of cardiac disease
  • Active systemic infection(s) or any other related illnesses
  • Known HIV, HBV, HCV
  • History of solid organ transplant, cardiovascular disease, inflammatory bowel disease, or underlying neuropathy
  • Conditions interfering with patient participation
  • Known or suspected allergy to study drugs
  • Pregnant or breast-feeding
  • Therapeutic coumadin
  • More than or equal to Grade 2 pre-exiting peripheral neuropathy

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gemcitabine/Nab-paclitaxel, Radiation and Surgery

Gemcitabine (neoadjuvant and adjuvant), intravenously, at a dose of 1000 mg/m2 given over 30-40 minutes, on Day 1 of every 28 day cycle for 2 cycles.

Nab-paclitaxel, intravenously, at a dose of 125 mg/m2 given over 30-40 minutes, on Days 1, 8, and 15 of every 28 day cycle for 2 cycles.

Radiation Therapy: 50.4 Gy in 28 fractions (1.8 Gy/fraction)

Surgery: Tumor resection and arterial resection/reconstruction
Drug: Gemcitabine
Other Names:
  • Gemzar
Radiation: Radiation Therapy
Drug: Nab-paclitaxel
Other Names:
  • Abraxane
Procedure: Surgical Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Type and the severity of side effects
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of surviving patients at 1 year after treatment
Time Frame: 1 year
1 year
Number of patients who disease has not progressed
Time Frame: 2 years
2 years
Number of patients that are able to receive surgery after chemoradiation
Time Frame: 5 years
5 years
Average length of hospital stay per patient
Time Frame: 5 years
5 years
Number of surviving patients at 30-days after surgery
Time Frame: 30 days after surgery
30 days after surgery
Number of surviving patients at 90-days after surgery
Time Frame: 90 days after surgery
90 days after surgery
Number of patients who need to be re-admitted to the hospital at 90-days after surgery
Time Frame: 90 days after surgery
90 days after surgery
Time to Progression
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Neesha Dhani, M.D., Princess Margaret Cancer Centre

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

July 1, 2016

Primary Completion (Actual)

December 10, 2024

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimated)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARCAP-GA

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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