Radiation + Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byMarsha Reyngold, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?The researchers are doing this study to test the combination of radiation therapy (RT) and low dose chemotherapy in people with metastatic pancreatic cancer that has a homologous recombination deficiency (HRD) and has spread to the liver. The researchers will try to find the highest safe and effective dose of individualized dose-painted RT that can be given to the liver when combined with standard low dose chemotherapy. The conformal dose painted RT treatment plan will include higher doses of radiation to the areas of the liver where tumors can be seen, and a lower dose to the entire liver. The study will also look at blood samples from participants to learn why some people may respond to study treatment (whole liver RT in combination with low dose chemotherapy) better than others.

Eligibility Criteria

This trial is for adults with pancreatic cancer that has spread to the liver and shows a specific genetic weakness (HRD). Participants can have had previous chemotherapy, including platinum-based treatments. They must have at least one measurable liver tumor and be in fairly good health overall. Women of childbearing age and men must use contraception.

Inclusion Criteria

My pancreatic cancer has spread to my liver.

My liver cancer is considered life-limiting even though it has spread outside the liver.

I am able to care for myself and move around.

+8 more

Exclusion Criteria

I am severely allergic to cisplatin.

I've had radiation in the same area as my current cancer.

I have a history of liver disease, such as cirrhosis, hepatitis, or hemochromatosis.

+5 more

Participant Groups

The study tests combining radiation therapy targeting the liver tumors with low dose chemotherapy (Gemcitabine and Cisplatin) in patients. It aims to find the safest high dose of targeted radiation that works well with this chemo regimen, while also studying participants' blood samples to understand treatment response variations.

1Treatment groups

Experimental Treatment

Group I: Radiation Therapy (RT) and ChemotherapyExperimental Treatment2 Interventions

Upon enrollment in the study, patients will undergo radiation simulation. Protocol therapy will start upon completion of RT planning (1-2 weeks). Chemoradiation will be initiated 1-2 weeks later depending on RT planning and consist of whole liver irradiation (WLI).

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: