A PHASE I DUAL DOSE ESCALATION STUDY OF RADIATION AND NAB-PACLITAXEL IN PATIENTS WITH UNRESECTABLE AND BORDERLINE RESECTABLE PANCREATIC CANCER
Bibliographic record
Abstract
This Phase I dual dose-escalation study aimed to evaluate the safety, feasibility, and toxicity profile of combining dose-escalated radiation therapy with high-dose nab-paclitaxel in patients with unresectable or borderline resectable pancreatic cancer. The primary objective was to determine the maximum tolerated radiation dose for the combination. Twenty-one evaluable patients were enrolled and allocated three radiation dose levels, 55 Gy, 57.5 Gy, and 60 Gy, administered over five weeks in 25 fractions. Concurrent nab-paclitaxel was given weekly at a dose of 125 mg/m 2 . Radiation dose escalation was guided by a time-to-event continual reassessment method. Toxicities were monitored and classified according to CTCAE v4.0, with dose-limiting toxicities (DLT) defined as Grade 3 or higher gastrointestinal events or substantial decline in performance status. Surgical resection was pursued in patients achieving sufficient tumour downstaging. Hematologic toxicities were the most common Grade ≥3 adverse events occurring in 76.2% of patients. Non-hematologic toxicities were less frequent (57.1%). Two Grade 3 gastrointestinal DLT cases occurred at dose levels 57.5 Gy and 60 Gy. The maximum tolerated dose was determined to be 60 Gy with a probability of DLT of 0.155 at this dose. Surgical resection with negative margins (R0) was achieved in 33.3% of patients, including all borderline resectable cases and 22.2% of initially unresectable cases. The median overall survival and time to local progression from the start of radiation therapy were 22.3 months and 20.3 months, respectively. This study demonstrates the feasibility and safety of combining dose-escalated radiation with high-dose nab-paclitaxel in locally advanced pancreatic cancer. The regimen is associated with manageable toxicity and promising local control and survival. These findings support further evaluation in larger trials to assess its impact on clinical outcomes.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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".