A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)
NRG Oncology
Summary
This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.
Description
PRIMARY OBJECTIVE: I. To evaluate whether dose-escalated radiation therapy (RT) improves 3-year overall survival (OS) compared to standard treatments without dose-escalated RT, in locally advanced pancreatic cancer patients without radiographic progression and with biochemical response after an initial interval of chemotherapy. SECONDARY OBJECTIVES: I. To evaluate and compare local progression between the two treatment arms. II. To evaluate and compare progression-free survival (PFS) between the two treatment arms. III. To evaluate and compare chemotherapy-free interval between the two tre…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine/nab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. "Active chemotherapy" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle * BASELINE PRE-ENTRY CHEMOTH…
Interventions
- ProcedureBiopsy Procedure
Undergo tumor tissue biopsy
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugCapecitabine
Given capecitabine
- ProcedureComputed Tomography
Undergo CT or PET/CT
- RadiationDose-escalated Radiation Therapy
Undergo dose-escalated radiation using intensity-modulated radiation therapy treatment planning
- DrugFluorouracil
Given fluorouracil
- DrugGemcitabine
Locations (279)
- Banner MD Anderson Cancer CenterGilbert, Arizona
- Arizona Center for Cancer Care - GilbertGilbert, Arizona
- Arizona Center for Cancer Care-PeoriaPeoria, Arizona
- Arizona Center for Cancer Care - PhoenixPhoenix, Arizona
- Arizona Center for Cancer Care - ScottsdaleScottsdale, Arizona
- Arizona Center for Cancer Care-SurpriseSurprise, Arizona