PANOVA-3: A phase 3 study of tumor treating fields (TTFields) with gemcitabine and nab-paclitaxel (GnP) for front-line treatment of locally advanced pancreatic adenocarcinoma.
Bibliographic record
Abstract
TPS629 Background: Tumor Treating Fields (TTFields) are a non-invasive, loco-regional antimitotic therapy approved for the treatment of glioblastoma and malignant pleural mesothelioma. TTFields (150–200 kHz) are delivered via arrays placed on the skin surrounding the tumor site. In vitro, TTFields (150 kHz), with or without chemotherapy, had antiproliferative and anticlonogenic effects on pancreatic cancer cells. The Phase 2 PANOVA study (NCT01971281) demonstrated the safety and preliminary efficacy of TTFields combined with nab-paclitaxel and gemcitabine (GnP) in both metastatic and locally advanced pancreatic adenocarcinoma (LAPC). Methods: The Phase 3 PANOVA-3 trial (NCT03377491) will evaluate the efficacy and safety of adding TTFields to GnP in a larger group of patients with LAPC. This prospective, randomized trial is currently enrolling 556 patients with unresectable LAPC (per National Comprehensive Cancer Network guidelines), Eastern Cooperative Oncology Group performance status of 0-2, and no prior progression or treatment. Patients will be randomized 1:1 to receive TTFields plus GnP or to GnP alone, stratified by performance status and geographical region. A recent protocol amendment included the use of a smaller, more light-weight (reduced from 6 to 2.7 lbs.) TTFields device. Standard doses of nab-paclitaxel (125 mg/m2) and gemcitabine (1000 mg/m2) will be administered on days 1, 8, and 15 of a 28-day cycle. TTFields (150 kHz) will be delivered ≥ 18 h/day until local disease progression per Response Evaluation Criteria In Solid Tumors Criteria V1.1. Follow-up visits will be conducted every 4 weeks; a computed tomography scan of the chest and abdomen will be performed every 8 weeks. After local disease progression, patients will be followed for survival on a monthly basis. The primary endpoint is overall survival (OS). Secondary endpoints include progression free survival (PFS), local PFS, objective response rate, 1 year survival rate, pain- and puncture-free survival rate, rate of resectability, quality of life, and toxicity. The sample size calculation used a log-rank test comparing time to event in patients treated with TTFields plus GnP with control patients on gemcitabine alone. PANOVA-3 is designed to detect a hazard ratio of 0.75 in OS. Type I error is set to 0.05 (2-sided) and power to 80%. Study locations in Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Hong Kong, Hungary, Israel, Italy, Poland, Spain, Switzerland, and the US are currently recruiting. Clinical trial information: NCT03377491.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.001 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.001 | 0.004 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".