Clinical Trials Logo

Clinical Trial Summary

This research study is a Phase II clinical trial, which evaluates a combination of drugs, FOLFIRINOX and Gemcitabine/Nab-Paclitaxel, in the management of participants with resectable pancreatic cancer prior to surgery.


Clinical Trial Description

Patients who fulfill eligibility criteria will be randomized to Arm A or Arm B

- Treatment will be administered on an outpatient basis.

- Upon registration participants will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).

- After completion of FOLFIRINOX or Gemcitabine/Nab-paclitaxel, all participants without progressive disease will proceed to radiation therapy with capecitabine .

- Between 2 and 4 weeks after radiation is complete, participants will proceed for surgical resection of pancreatic cancer ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02243007
Study type Interventional
Source Massachusetts General Hospital
Contact David Ryan, MD
Phone 617-724-4000
Email DPRYAN@PARTNERS.ORG
Status Recruiting
Phase Phase 2
Start date September 2014
Completion date March 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05209074 - Ivosidenib + mFOLFIRINOX in Patients With Resectable Pancreatic Adenocarcinoma Phase 1
Not yet recruiting NCT05529940 - NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer) Phase 3
Terminated NCT02345460 - Preoperative Folfirinox for Resectable Pancreatic Adenocarcinoma - A Phase II Study Phase 2
Recruiting NCT05679050 - Phase II Study on Sequential AG and FOLFIRINOX as Neoadjuvant Therapy in Patients With Resectable Pancreatic Cancer Phase 2
Withdrawn NCT01694589 - A Pilot Study of a Hedgehog Pathway Inhibitor (LDE-225) in Surgically Resectable Pancreas Cancer Phase 0
Active, not recruiting NCT03138720 - Pre-operative Treatment for Patients With Untreated Pancreatic Cancer Phase 2
Completed NCT01298011 - Study of Gemcitabine and Abraxane to Treat Potentially Operable Pancreatic Cancer Phase 2
Recruiting NCT04810910 - Personalized Neoantigen Vaccine in Pancreatic Cancer Patients Following Surgical Resection and Adjuvant Chemotherapy Phase 1
Completed NCT01992705 - Borderline Pancreas Study: FOLFIRINOX +SBRT Early Phase 1
Completed NCT02047513 - Neoadjuvant Plus Adjuvant or Only Adjuvant Nab- Paclitaxel Plus Gemcitabine for Resectable Pancreatic Cancer Phase 2
Completed NCT02115022 - EUS vs. MDCT in Pancreatic Malignancy
Recruiting NCT03492671 - Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer Phase 2
Terminated NCT05546411 - A Trial of NIS793 With FOLFIRINOX in Pancreatic Cancer Phase 2
Not yet recruiting NCT06172036 - Irinotecan Liposome for Resectable Pancreatic Cancer With or Without Addebelizumab Phase 2
Recruiting NCT05788744 - Implementing ctDNA and Circular DNA in Patients With Localized Pancreatic Cancer N/A
Recruiting NCT04737551 - Adjuvant Chemoradiation Following Radical Resection of Pancreatic Ductal Adenocarcinoma, a Prospective Cohort Study
Recruiting NCT03822936 - Carbon Ions Radiation Therapy for Resectable or Borderline Resectable Pancreas Adenocarcinoma Phase 2
Completed NCT03435536 - Surgery Impact on Circulating Tumor DNA in Pancreatic Cancer N/A
Terminated NCT05380557 - ARTEMIS: Study of Patients With Early Stage Pancreatic Cancer Who Have Undergone Genetic Testing
Active, not recruiting NCT04472910 - GATA6 Expression as a Predictor of Response to Peri-Operative Chemotherapy in Resectable Pancreatic Adenocarcinoma N/A