A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With … (NCT02481635) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Gemcitabine/Nab-paclitaxel and Radiation Therapy Followed by Surgery in Patients With Advanced Pancreatic Cancer
Canada30 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …