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

PHASE1CompletedINTERVENTIONAL
Enrollment

1

Participants

Timeline

Start Date

December 20, 2021

Primary Completion Date

November 4, 2024

Study Completion Date

November 4, 2024

Conditions
Pancreatic Cancer
Interventions
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.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center (All protocol activities), New York

10604

Memorial Sloan Kettering Westchester (All Protocol Activities), East White Plains

11553

Memorial Sloan Kettering Nassau (All Protocol Activities), Rockville Centre

11725

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities), Commack

07920

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge

07748

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT05182112 - Radiation Therapy (RT) and Chemotherapy for the Treatment of Pancreatic Cancer with Homologous Recombination Deficiency That Has Spread to the Liver | Biotech Hunter | Biotech Hunter