Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer (LAP100)

This research study will test whether higher doses of radiation therapy are safe and effective for people with locally advanced pancreatic cancer. The goal is to see if stronger doses can shrink or control the cancer better than standard doses, without causing too many side effects. People who have been diagnosed with locally advanced pancreatic cancer and have not had surgery to remove the tumor may be eligible.

People will be selected at random for one of two groups. 

Group 1 (Standard-of-Care Group):

Participants in Group 1:

• will receive 4-6 months of chemotherapy as directed by their doctor.
• who require radiation will receive standard dose radiation therapy once daily for 28 days and receive fluorouracil or capecitabine during radiation therapy.
• will be encouraged to receive at least 6 months of chemotherapy. Participants may continue treatment beyond 6 months based on their doctor's recommendation.
• will provide blood samples, CT scans, MRI scans and tumor tissue biopsy throughout the study. 

Group 2 (Dose Escalated Radiation Therapy Group): 

Participants in Group 2:

• will receive 4-6 months of chemotherapy as directed by their doctor.
• will receive dose-escalated radiation therapy every other day, or twice weekly, for 5 weeks or daily for 25 days. 
• who received less than 6 months of chemotherapy at the beginning of the study will be encouraged to reeive the remaining chemotherapy to total 6 months of chemotherapy. Participants may continue treatment beyond 6 months if directed by their doctor.
• will provide blood samples, CT scans, MRI scans and tumor tissue biopsy throughout the study. 

After completion of study treatment, all participants will be followed every 3 months for 2 years then annually for 3 years.

People may be eligible if they:

• have been diagnosed with locally advanced pancreatic cancer (cancer that has not spread to distant parts of the body but cannot be removed by surgery). 
• have received 4-6 months of chemotherapy with one of the following regimens:
  • folfirinox (8-12 cycles).  
  • nalirifox (8-12 cycles).  
  • gemcitabine/nab-paclitaxel (4-6 cycles).

After receiving chemotherapy, patients may be eligible if: 

• their staging scans showing at least stable disease (no progression).
• if their biomarker test CA19-9 drops or remains stable:
  • for participants whose baseline (before chemotherapy) CA19-9 was elevated (defined as > 37 u/mL) after chemotherapy their CA19-9 must be less than 37 u/mL or show a 50% drop from pre-chemotherapy level with absolute value less than 100u/mL.
  • for participants whose baseline (before chemotherapy) CA19-9 was not elevated (defined as 37 u/mL or less), the post-pre-entry chemotherapy CA19-9 must remain 37 u/mL or less.​​​​​

Participants are not eligible if they:

• have active duodenal (small intestine) or gastric (stomach) ulcers.
• have a tumor that has invaded the bowel or stomach.
• are pregnant or breastfeeding. 
• have a heart condition resulting in hospitatlization in the last 6 months