Study on Combining Chemotherapy and Radiation Before Surgery for Localized Pancreatic Cancer

Program Overview

The aim of this study is to find out if giving chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy before surgery can help surgeons completely remove pancreatic cancer. This approach is being tested to see if it increases the likelihood of achieving an R0 resection, which means no cancer cells are left behind. The study will also look at how long patients stay cancer-free, their overall survival, and any complications related to the treatment and surgery.

Description

In this study, patients will receive chemotherapy and radiation therapy before surgery to see if it helps in completely removing the cancer. The chemotherapy drugs used are gemcitabine and nab-paclitaxel, which are already approved for treating pancreatic cancer. The treatment will start within 28 days of joining the study.

Pre-operative Chemotherapy:

• Patients will receive gemcitabine and nab-paclitaxel for up to four cycles before surgery.
• Gemcitabine will be given intravenously on days 1, 8, and 15 of each 28-day cycle.
• Nab-paclitaxel will also be given intravenously on days 1, 8, and 15 of each 28-day cycle.

Post-operative Chemotherapy:

• After surgery, patients will receive the same chemotherapy drugs for up to two cycles, starting 5-10 weeks after surgery.

Radiation Therapy:

• Patients will undergo a CT scan for treatment planning and will be immobilized during radiation therapy.
• Radiation side effects will be monitored and scored according to standard criteria.

Surgery and Evaluation:

• Surgery should take place 4-10 weeks after the last dose of pre-operative chemotherapy.
• Pre-operative evaluations will determine if the patient should proceed to surgery.
• Post-operative evaluations will occur within 2 weeks before starting post-operative chemotherapy.

The study will assess the tumor's response to treatment and monitor for any progression of the disease.

Eligibility Criteria