Trial · NCT07592819
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Outcome Measure | From treatment initiation through 1 year | Event-Free Survival is defined as the time from the start of treatment to the occurrence of any of the following events: * disease progression, * failure to undergo pancreatic resection, * death from any cause, * grade IV febrile neutropenia or grade IV diarrhea occurring during neoadjuvant chemotherapy. Participants without an event will be censored at the date of last follow-up. |
| Secondary | Objective Response Rate (ORR) | During neoadjuvant chemotherapy (up to 16 weeks) | Percentage of participants achieving a complete response or partial response per RECIST 1.1 criteria. |
| Secondary | Overall Survival (OS) | From treatment initiation through study completion (up to 18 months) | Time from start of treatment to death from any cause. |
| Secondary | Progression-Free Survival (PFS) | From treatment initiation through study completion (up to 18 months) | For non-operated patients: time from treatment initiation to disease progression or death from any cause. |
| Secondary | Recurrence-Free Survival (RFS) | From treatment initiation through study completion (up to 18 months) | For operated patients: time from treatment initiation to first local or metastatic recurrence or death. |
| Secondary | Disease Control Rate (DCR) | During neoadjuvant chemotherapy (up to 16 weeks) | Percentage of patients achieving complete response, partial response, or stable disease. |
| Secondary | Tumor Regression Grade (TRG) | At time of surgery | Pathologic tumor response assessed using Ryan's simplified Tumor Regression Grade (TRG 1-3) on the resected primary tumor. |
| Secondary | Postoperative Complications (Clavien-Dindo Classification) | Within 60 days after surgery | Postoperative complications graded from I to V according to Clavien-Dindo. |
| Secondary | Time to Recurrence (TTR) | Up to 18 months | Time from treatment initiation to first recurrence (local or metastatic) or death related to cancer. |
| Secondary | Quality of Life (EORTC QLQ-C30 ) | From baseline through study completion (up to 18 months) | Change over time in the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). |
| Secondary | Completion Rate of Neoadjuvant Chemotherapy (NAC) | End of the 4-month NAC period | Percentage of participants who completed all 8 cycles of mFOLFIRINOX (regardless of dose modifications). |
| Secondary | Adverse Events and Toxicities (NCI-CTCAE v5.0) | Before each chemotherapy cycle (Weeks 0-16) | Incidence and severity of treatment-related toxicities graded according to NCI-CTCAE v5.0. |
| Secondary | ime to First Deterioration in Global Health Status | From treatment initiation through study completion (up to 18 months) | Time to first deterioration of more than 5 points from baseline in the EORTC QLQ-C30 global health status score. |
| Secondary | Pancreatic Cancer-Specific Quality of Life (EORTC QLQ-PAN26) | From baseline through study completion (up to 18 months) | Change over time in symptom and functional scores assessed using the EORTC QLQ-PAN26 pancreatic |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07592819/registered