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A Study of NALIRIFOX in Combination With Radiation Therapy in People With Pancreatic Ductal Adenocarcinoma (PDAC)

StatusRecruiting
PhasePhase 2
Started2023-05-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 1, 2026 → Sep 1, 2027
See other at-risk trials from Memorial Sloan Kettering Cancer Center

Amendment history

2026-09-01
Study Status, Contacts/Locations v7
Primary completion pushed: 2026-09-01 → 2027-09-01
Completion pushed: 2026-09-01 → 2027-09-01
Primary completion moved earlier: 2027-05 → 2026-09-01
Completion moved earlier: 2027-05 → 2026-09-01
Study sitesdetails revised at 5 of 7 sites
2026-06-04
Study Status v6
Primary completion date2026-05→2027-05
Completion date2026-05→2027-05
2025-06-04
3 amendments v3-v5
3 re-verifications since 2023-12-27, no change to tracked fields
2023-09-22
Study Status, Eligibility v2
Eligibility criteria-324 characters
[...] cer, and basal cell or squamous cell carcinoma of the skin. DeterminedA multidisciplinary discussion has been undertaken/planned which can include (a) discussion with medical/surgery oncology, (b) Hepatopancreaticobiliary Disease Management Team conference presentation, (c) direct consultation, with confirmation on consensus plan for TNT strategy and potential for fut [...] to be medicallydocumented fitin forthe curativemedical intentrecord pancreatectomyprior byto treatinginitiation surgeonof treatment. Male or nonpregnant and nonlactating female aged ≥18 years. [...] ogical, biochemical, and organ functi [...]
2023-05-15
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-05→confirmed 2023-05-12
Study sitesdetails revised at 7 of 7 sites
2023-05-01
Original filing
The researchers are doing this study to find out whether using the chemotherapy regimen NALIRIFOX in combination with ablative dose radiation therapy (AD-XRT) and the standard chemotherapy drug capecitabine is an effective treatment approach for people with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC) before surgery. This type of treatment approach is called total neoadjuvant therapy (TNT). The researchers will also look at whether the sequence of the treatment approach (NALIRIFOX + ADXRT and capecitabine followed by surgery, when it is possible) is effective and causes few or mild side effects in participants. An important purpose of the study is to see how the study treatment (NALIRIFOX + AD-XRT and capecitabine) affects participants' quality of life. The researchers will measure quality of life by having participants fill out questionnaires
Trial Details
NCT Number NCT05851924
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Ipsen, Pancreatic Cancer Research Fund
Conditions Pancreatic Ductal Adenocarcinoma
Enrollment 60 participants
Start Date 2023-05-12
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-17