Trial Outcomes & Findings for Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer (NCT NCT01494155)

Short Course Radiation Therapy With Proton or Photon Beam Capecitabine and Hydroxychloroquine for Resectable Pancreatic Cancer

Progression-free survival (PFS) will be defined as the time from the start of treatment until the first objective documentation of progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, or death. PFS is reported as the number of participants without PD after 2 years and 4 years on study. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Progressive disease (PD) is defined as at least a 20% increase in the sum of longest the diameters of target lesions, taking as reference the baseline sum diameters. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Pathological complete response (pCR) will be defined as the absence of any viable tumor cells within the tissue samples removed during surgery.

Overall survival (OS) is defined as the time from start of study therapy to date of death and will be reported as the number of patients alive after 2 years and 4 years on study. Participants who have not died will be censored at the date they were last known to be alive.

Treatment-emergent adverse events (TEAEs) are grade 3 or higher AEs as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4, and at least possibly related to study treatment capecitabine + hydroxychloroquine and short course radiation therapy. TEAEs are AEs that began after the start of study treatment; or if the event was continuous from baseline and was serious, at least possibly related to study treatment, or resulted in death, discontinuation, or interruption or reduction of study treatment. Participants with multiple occurrences of TEAEs are counted only once per specific category in CTCAE v4.

Surgical morbidity is defined as adverse events during an operation and up to 30 days afterwards, grade 3 or higher and at least possibly related to surgery as assessed by the CTEP Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.

Post-operative mortality is defined as death within 30 days after surgery.

Pathologic downstaging (pDS) is defined as a change in the tumor stage from pre-treatment clinical staging to the final pathology of the surgically removed tumor after receiving neoadjuvant treatment (i.e., treatment given before surgery).

Local control is defined as the time from the start of study treatment to the date of local failure; this outcome is reported below as the number of participants without local failure at 2 years after start of study treatment. Local failure is defined as progressive disease (PD) of the main tumor or at the margins of where the main tumor was surgically removed, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v1.1 below: * At least a 20% increase in the longest diameter of target tumor lesion and an absolute increase of at least 5 mm, taking as reference the baseline measurement. * The appearance of one or more new lesions is also considered progression. Patients who have not experienced a local failure will be censored at the last date they were known to have local control.