Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNRG Oncology

About this trial

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.

Eligibility criteria

Qualifiers

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

Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma

Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network [NCCN] guidelines and institutional tumor board review)

Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest/abdomen/pelvis, CT chest/MRI abdomen/pelvis, CT chest/CT pelvis/MRI abdomen, or PET/CT performed prior to enrollment

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biopsy Procedure
  • Biospecimen Collection
  • Capecitabine
  • Computed Tomography
  • Dose-escalated Radiation Therapy
  • Fluorouracil
  • Gemcitabine
  • Irinotecan Hydrochloride
  • Irinotecan Sucrosofate
  • Leucovorin Calcium
  • Magnetic Resonance Imaging
  • Nab-paclitaxel
  • Observation Activity
  • Oxaliplatin
  • Positron Emission Tomography
  • Questionnaire Administration
  • Radiation Therapy

Treatment groups

356 Participants
are divided into 2 treatment groups

Sponsors and collaborators