Table 2:

Select ongoing or completed Phase II and III trials in pancreatic ductal adenocarcinoma to answer specific questions

Title (Clinical trial No.)Study typeTreatment armPlanned no. of patientsSpecific inclusionQuestion to be answeredPrimary outcome
Resectable or borderline resectable PDAC
ALLIANCE (A02180 PAC3)Phase IIIPerioperative modifed
FOLFIRINOX v. surgery and adjuvant modified FOLFIRINOX
344Resectable PDACIs a neoadjuvant approach superior to surgery first followed by adjuvant?OS
PANDAS-PRODIGE-44 (NCT02676349)Phase IIFOLFIRINOX–surgery–adjuvant chemotherapy
FOLFIRINOX–chemoradiotherapy (capecitabine/50.4Gy)–surgery–adjuvant chemotherapy
90Resectable and BR; ECOG 0 or 1; Age 18–75 yrDoes additional conformal chemoradiation preoperatively improve R0 resection rates?R0 resection rate
Locally advanced PDAC
CROSSFIRE (NCT02791503)Phase IIFOLFIRINOX and IRE; FOLFIRINOX and SABR138LAPCFollowing FFX, which has better efficacy, IRE or SABR?OS
CONKO-007 (NCT01827553)Phase IIIInduction chemotherapy with gemcitabine or FOLFIRINOX, followed by radiotherapy induction chemotherapy with gemcitabine or FOLFIRINOX alone830LAPC; ECOG ≤ 2Does chemoradiotherapy postinduction chemotherapy compared with chemotherapy alone improve outcomes in LAPC?OS
Advanced or metatstatic PDAC
CCTG PA.738Phase IIGemcitabine/nab-paclitaxel; Gemcitabine/nab-paclitaxel plus durvalumab plus tremelimumab180ECOG 0/1; Measureable diseaseDoes the addition of combination PD-L1 and CTLA-4 inhibition added to chemotherapy improve survival?OS
PANC003 (NCT03504423)Phase IIIModified FOLFIRINOX; Modified FOLFIRINOX and CPI-613500Stage IV; ECOG 0/1Does CPI 613, a drug targeting the mitochondrial tricarboxylic cycle, improve outcomes in metastatic pancreatic cancer?ORR
PFS
PASS-01 (NCT04469556)Phase IIModified FOLFIRINOX; Gemcitabine/nab-paclitaxel150Stage IV; absence of germline mutationIs modified FOLFIRINOX superior to gemcitabine/nab-paclitaxel in the management of stage IV pancreatic cancer?PFS
  • Note: BR = borderline resectable, CTLA-4 = cytotoxic T-lymphocyte-associated protein, ECOG = Eastern Cooperative Oncology Group, FFX= FOLFIRINOX, IRE = irreversible electroporation, LAPC = locally advanced pancreatic ductal adenocarcinoma, ORR = overall response rate, OS = overall survival, PD-L1 = programmed-death ligand 1, PDAC = pancreatic ductal adenocarcinoma, PFS = progression-free survival, SABR = stereotactic ablative radiation.