NCT02481635CompletedPhase 1/2
A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
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
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 23 Jun 2015
- Start date
- 8 Dec 2016
- Primary completion date
- 30 May 2024
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Pancreatic cancer
- NCT number
- NCT02481635
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 11
- From 8 Dec 2016 to the primary completion date, 30 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Surgical:
- Concurrent cancer diagnosis
- Prior radiotherapy or chemo within 1 year, to pancreas
- Bone marrow transplant/stem cell rescue
- Major surgery \<4 wks prior
Other illness
- Disease progression on neo-adjuvant treatme
- General:
- 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
Age
- Other malignancies unless all therapy completed, no disease for \>=3 years
Other
- Aortic involvement
- Involvement of 2 major arterial trunks
- SMV/portal venous occlusion, cannot be reconstructed
- Extensive venous involvement, no arterial involvement
- Distant metastases
- Renal dysfunction
- Pregnant or breast-feeding
- Therapeutic coumadin
- More than or equal to Grade 2 pre-exiting peripheral neuropathy
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.