NCT05182112

Radiation Therapy (RT) and Chemotherapy for the Treatment of Pancreatic Cancer with Homologous Recombination Deficiency That Has Spread to the Liver

Phase I Study of Precision CRT for Liver-Dominant Metastatic Pancreatic Cancer with Homologous Recombination Deficiency (PreCISeRT)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	Whole liver irradiation (WLI)	Whole liver irradiation (WLI) to a total dose 1800cGy in 10 fractions will be given over 2 weeks with simultaneously integrated boost (SIB) to deliver focal doses of 3600cGy (dose level 1) and 4800cGy (dose level 2) to select gross lesions. SIBl dose assignment will be according to the dose escalation scheme, with all patients in dose level 1 receiving boost of 3600cGy to select lesions and those in dose level 2 receiving boosts of 4800cGy to select lesions. At least one lesion will be selected for dose escalation.
DRUG	Gemcitabine and Cisplatin	Patients will start cisplatin 10 mg/m2 and gemcitabine 600 mg/m2 intravenously q2 weeks for 1 cycle while undergoing simulation and radiation treatment planning procedures. After completion of CRT, adjuvant cisplatin 25 mg/m2 and gemcitabine 600 mg/m2 q2 weeks will be continued until progression or unacceptable toxicity.

Timeline

• Start date: 2021-12-20
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2022-01-10
• Last updated: 2024-11-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study