NCT02481635

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Jul 2016

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

December 8, 2025

Status Verified

December 1, 2025

Enrollment Period

8.4 years

First QC Date

June 23, 2015

Last Update Submit

December 1, 2025

Conditions

Pancreatic Cancer

Keywords

Blood VesselsReconstructive Surgery

Outcome Measures

Primary Outcomes (1)

  • Type and the severity of side effects

    5 years

Secondary Outcomes (8)

  • Number of surviving patients at 1 year after treatment

    1 year

  • Number of patients who disease has not progressed

    2 years

  • Number of patients that are able to receive surgery after chemoradiation

    5 years

  • Average length of hospital stay per patient

    5 years

  • Number of surviving patients at 30-days after surgery

    30 days after surgery

  • +3 more secondary outcomes

Study Arms (1)

Gemcitabine/Nab-paclitaxel, Radiation and Surgery

EXPERIMENTAL

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: GemcitabineDrug: Nab-paclitaxelRadiation: Radiation TherapyProcedure: Surgical Resection

Interventions

GemcitabineDRUG
Also known as: Gemzar
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Nab-paclitaxelDRUG
Also known as: Abraxane
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Radiation TherapyRADIATION
Gemcitabine/Nab-paclitaxel, Radiation and Surgery
Surgical ResectionPROCEDURE
Gemcitabine/Nab-paclitaxel, Radiation and Surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +3 more criteria

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelRadiotherapy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and ProteinsTherapeutics

Study Officials

  • Neesha Dhani, M.D.

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

June 25, 2015

Study Start

July 1, 2016

Primary Completion

December 10, 2024

Study Completion

January 1, 2026

Last Updated

December 8, 2025

Record last verified: 2025-12

Locations

CA(1)