Table 4.
Pending results from randomized trials regarding either adjuvant or combined neoadjuvant and adjuvant treatments in resectable pancreatic cancer, as listed on www.clinicaltrials.gov, www.clinicaltrialsregister.eu and www.umin.ac.jp by September 2019.
| Identifiers | Phase | Planned Accrual | Interventions | Primary Endpoint | Estimated Study Completion Date—Status |
|---|---|---|---|---|---|
| GIP-2 NCT02355119 | III | 310 | Gem vs. FOLFOXIRI | DFS | Dec, 2018—status unknown |
| IMPRESS NCT01072981 | III | 722 | Gem ± 5FU-based CRT vs. Gem ± CRT + Alg | OS | May, 2016—anticipated negative results |
| NCT02005419 | IIR | 300 | Gem vs. Gem + Met | 1-y RFS | Dec, 2017 |
| NEPAFOX NCT02172976 | II/III | 40 | Perioperative FOLFIRINOX vs. adjuvant Gem | OS | Jul, 2019 |
| RTOG 0848 NCT01013649 | II/III | 545 | Combination CT/Gem vs. Erl + Gem, followed by previous CT ± 5FU/Cap-based CRT | OS | Aug, 2020—partial preliminary results |
| HEAT NCT01077427 | III | 336 | Gem + Cis + regional hyperthermia vs. Gem + Cap | DFS | Mar, 2021 |
| SWOG S1505 NCT02562716 | IIR | 112 | Perioperative FOLFIRINOX vs. perioperative nabP + Gem | OS | Oct, 2021 |
| NCT02451982 | I/IIR | 75 | Perioperative CTX + GVAX + Gem + RT vs. perioperative CTX + GVAX + Niv ± Ure + Gem + RT | IL-17A expression in resected tumors | Feb, 2023 |
| NCT03959150 | II/III | 231 | Gem + Cap followed by metronomic Cap vs. Gem + Cap | 1-y DFS | Jun, 2023 |
| NEONAX NCT02047513 | IIR | 166 | Perioperative nabP + Gem vs. adjuvant nabP + Gem | DFS | Sep, 2024 |
Abbreviations: 5FU = fluorouracil; Alg = algenpantucel-L; Cap = capecitabine; Cis = cisplatin; CRT = chemoradiation therapy; CT = chemotherapy; CTX = cyclophosphamide; DFS = disease-free survival; Erl = erlotinib; Gem = gemcitabine; IL = interleukin; Met = metformin; nab = nab-paclitaxel; Niv = nivolumab; OS = overall survival; RFS = relapse-free survival; RT = radiotherapy; SBRT = stereotactic body radiation therapy; Ure = urelumab; y = year; GIP-2: Gruppo Italiano Pancreas-2; RTOG: Radiation Therapy Oncology Group; HEAT: Hyperthermia European Adjuvant Trial; SWOG: Southwest Oncology Group; NEONAX: Neoadjuvant Plus Adjuvant or Only Adjuvant Nab-Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer; FOLFOXIRI: Combination of 5-Fluorouracil/Folinic Acid, Oxaliplatin and Irinotecan GVAX: immune system activating pancreatic cancer vaccine.