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Pancreatic CancerPhase 1/2NCT02481635

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

A Phase 1/2 study testing Gemcitabine, Nab-paclitaxel and Radiation Therapy in people with Pancreatic Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
Gemcitabine, Nab-paclitaxel and Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteCanada
Study dates
8 Dec 2016to 10 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Gemcitabine, Nab-paclitaxel, Radiation Therapy, Surgical Resection
Keywords
Blood Vessels, Reconstructive Surgery
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineDrug

    Also called Gemzar

  • Nab-paclitaxelDrug

    Also called Abraxane

  • Radiation TherapyRadiation

  • Surgical ResectionProcedure or surgery

Study groups in NCT02481635
Study groupRoleWhat they receive
Gemcitabine/Nab-paclitaxel, Radiation and SurgeryExperimentalGemcitabine (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
Receives: Drug: Gemcitabine; Drug: Nab-paclitaxel; Radiation: Radiation Therapy; Procedure: Surgical Resection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Type and the severity of side effects

    Measured: 5 years

Secondary outcomes (8)

  1. Number of surviving patients at 1 year after treatment

    Measured: 1 year

  2. Number of patients who disease has not progressed

    Measured: 2 years

  3. Number of patients that are able to receive surgery after chemoradiation

    Measured: 5 years

  4. Average length of hospital stay per patient

    Measured: 5 years

  5. Number of surviving patients at 30-days after surgery

    Measured: 30 days after surgery

  6. Number of surviving patients at 90-days after surgery

    Measured: 90 days after surgery

  7. Number of patients who need to be re-admitted to the hospital at 90-days after surgery

    Measured: 90 days after surgery

  8. Time to Progression

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2015 (estimated)
  2. Study start8 Dec 2016
  3. Primary completion30 May 2024
  4. Study completion10 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02481635
Sponsor's protocol ID
ARCAP-GA
Status last verified
Jul 2026
First submitted
23 Jun 2015
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gemcitabine, Nab-paclitaxel and Radiation Therapy in people with Pancreatic Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Type and the severity of side effects (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02481635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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