Clinical trialPhase 2Terminated

Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma

Phase II Study to Evaluate Neoadjuvant Modified FOLFIRINOX and Stereotactic Body Radiation Therapy in Borderline Resectable Pancreatic Adenocarcinoma

NCT03099265 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Stopped earlyPaused due to COVID. A determination was made to stop the study because it would be impossible to reach the 65% resection rate as outlined in the protocol. (Other)
Phase: Phase 2
Status: Terminated
Study type: Interventional
Start: 26 June 2017
Expected end: 18 September 2019
Enrollment: 9 participants
Sites: 1
Primary outcomes: Number of Participants With and Without R0 Resection
Sponsor: Other
Results posted: 2022-10-27
Last update: 27 October 2022

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Brief summary public domain (ClinicalTrials.gov)

Surgical resection is the only potentially curative treatment for patients with pancreatic cancer. Patients with BRPC have tumors in close contact with the vasculature but not to the extent that resection is prohibited. Nonetheless, retrospective studies have shown that immediate resection in these patients is associated with an increased risk of positive margins, and a margin positive resection does not improve survival over that of patients with unresectable disease. Moreover, even in those patients where a successful resection is achieved, there is a high rate of early metastatic progression suggesting that micrometastatic disease is often present at diagnosis. Therefore neoadjuvant therapy is likely to improve outcomes in patients with BRPC to increase the likelihood of achieving a margin negative resection, provide early control of occult micrometastatic disease, and select those patients without systemic progression who would benefit from surgical resection.

Detailed description public domain (ClinicalTrials.gov)

Given the superior outcomes with FOLFIRINOX and the potential for improved local response with SBRT, the investigators propose to evaluate the efficacy of pre-operative modified FOLFIRINOX followed by SBRT in patients with borderline resectable pancreatic adenocarcinoma. The investigators hypothesize that pre-operative modified FOLFIRINOX followed by SBRT will improve the rate of R0 resections compared to historical controls treated with standard gemcitabine-based chemotherapy and fractionated radiation prior to surgery.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With and Without R0 Resection [Up to 40 weeks]. Count Of Participants, Participants. Yes: Patients With Borderline Resectable Pancreatic Adenocarcinoma (n=9): 2. No: Patients With Borderline Resectable Pancreatic Adenocarcinoma (n=9): 7.