Neoadjuvant Accelerated Short Course Radiation Therapy With Photons and Capecitabine for Resectable Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

The purpose of this research study is to determine if it is possible to deliver high dose radiation in one week while also giving the drug capecitabine for the treatment of pancreatic cancer prior to surgery, to determine if this treatment can be given safely for the treatment of pancreatic cancer prior to surgery and, to determine if this treatment can improve the local control pancreatic cancer prior to surgery compared to historical controls of standard treatment.

Detailed description public domain (ClinicalTrials.gov)

OBJECTIVES: Primary * Phase I: To determine the feasibility and tolerability of radiation therapy for pancreatic cancer delivered with high dose external beam radiation in a one week accelerated schedule with concurrent capecitabine * Phase II: To demonstrate a grade 3 or greater (any) toxicity rate of less than 20% Secondary * To determine local control and recurrence patterns of pancreatic cancer relative to a standard regimen of 50.4 Gy as seen in historical controls * To determine the pathologic response rate * To determine the progression-free survival * To determine the surgical morbidity * To determine 30-day post-operative mortality after pancreatic resection

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Neoadjuvant Short-Course Photon Radiation Therapy Maximum Tolerated Dose (MTD) [Phase I] [within 3 weeks of the start of chemoradiation therapy]. Number, Gy per fraction. All Phase I: Photon Rad+Capecitabine (n=10): NA [The study was closed early due to unexpected intraoperative complications. No patients developed a pre-specified DLT in the 10 treated patients. The MTD was not established.].

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Dose Limiting Toxicity (DLT) [Phase I] [within 3 weeks of the start of chemoradiation therapy]. Number, patients with DLT. Phase 1 Cohort 1: Photon Rad (30 Gy/12 Days)+Capecitabine (n=3): 0; Phase I Cohort 2: Photon Rad (25 Gy/11 Days)+Capecitabine (n=3): 0; Phase I Cohort 3: Photon Rad (25 Gy/5 Days)+Capecitabine (n=4): 0.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Grade 3-5 Toxicity Rate [Phase II] [within 3 weeks of the start of chemoradiation therapy].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Local Recurrence Rate [Phase II] [Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Pathologic Response Rate [Phase II] [Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression-Free Survival (PFS) [Phase II] [Disease was assessed radiologically at baseline and after treatment every 6 months for first 2 years and annually in years 3-5.].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Surgical Morbidity Rate [Phase II] [Assessed after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Surgical Mortality Rate [Phase II] [Assessed up to 30 days after resection; Patients underwent resection of their pancreatic cancer up to 3 weeks after completion of chemoradiation therapy].