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

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT02481635
• Date of registration: 23/06/2015
• Prospective Registration: Yes
• Primary sponsor: University Health Network, Toronto
• Public title: A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
• Scientific 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
• Date of first enrolment: July 2016
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02481635
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Canada

Contacts

• Name: Neesha Dhani, M.D.
• Affiliation: Princess Margaret Cancer Centre

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pancreatic Cancer

Intervention(s)

Drug: Gemcitabine

Drug: Nab-paclitaxel

Radiation: Radiation Therapy

Procedure: Surgical Resection

Primary Outcome(s)

Type and the severity of side effects [Time Frame: 5 years]

Secondary Outcome(s)

Time to Progression [Time Frame: 5 years]

Number of patients who need to be re-admitted to the hospital at 90-days after surgery [Time Frame: 90 days after surgery]

Number of patients who disease has not progressed [Time Frame: 2 years]

Number of surviving patients at 30-days after surgery [Time Frame: 30 days after surgery]

Number of surviving patients at 90-days after surgery [Time Frame: 90 days after surgery]

Number of patients that are able to receive surgery after chemoradiation [Time Frame: 5 years]

Number of surviving patients at 1 year after treatment [Time Frame: 1 year]

Average length of hospital stay per patient [Time Frame: 5 years]

Secondary ID(s)

ARCAP-GA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors