CompletedPhase 2

Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

United States20 participantsStarted 2016-01-21

Plain-language summary

This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by radiation therapy before surgery work in treating patients with pancreatic cancer that can be removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects must have histologically or cytologically confirmed adenocarcinoma of the pancreas * Tumors must be localized (non-metastatic) and classified as borderline resectable according to Americas Hepato-Pancreato-Biliary Association (AHPBA)/Society of Surgical Oncology (SSO)/Society for Surgery of the Alimentary Tract (SSAT) consensus criteria or be clinically node-positive via computed tomography (CT) or endoscopic ultrasound * AHPBA/SSO/SSAT criteria (any one of the following): * Tumor-associated deformity of the SMV (superior mesenteric vein) or PV (portal vein) * Abutment of the SMV or PV \>= 180 degrees * Short-segment occlusion of the SMV or PV amenable to resection and venous reconstruction * Short-segment involvement of the hepatic artery or its branches amenable to resection and reconstruction * Abutment of the superior mesenteric artery (SMA) \< 180 degrees * Subjects must have measurable disease (by RECIST 1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan * No prior therapy for pancreatic cancer, including chemotherapy, radiation therapy, definitive surgery or investigational therapy * Members of all races and ethnic groups will be included * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 …

What they're measuring

R0 Resection Rate Defined as Macroscopically Complete Tumor Removal With Negative Microscopic Surgical Margins by Pathologic Assessment

Timeframe: At the time of surgery

Trial details

NCT IDNCT02427841

SponsorOHSU Knight Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-12

Results submitted2020-10-26