Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
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ClinicalTrials.gov Identifier: NCT01926197 |
Recruitment Status :
Active, not recruiting
First Posted : August 20, 2013
Last Update Posted : June 14, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatic Cancer | Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU | Phase 3 |
A Pancreatic Cancer Radiotherapy Study Group (PanCRS) Trial
Primary Objective:
To determine progression free survival for mFFX +/- SBRT.
Secondary Objectives:
- To determine metastasis free survival following mFFX chemotherapy alone or with SBRT.
- To determine the overall survival in pancreatic cancer patients treated with chemotherapy +/- SBRT.
- To determine local progression-free survival in pancreatic cancer patients after chemotherapy +/- SBRT.
- To evaluate acute (within 3 months of treatment) grade 2 or greater gastritis, fistula, enteritis, or ulcer and any other grade 3-4 gastrointestinal toxicity within 3 months of treatment.
- To evaluate the utility of FDG-PET for treatment planning and estimation of progression free survival.
- To identify new biomarkers in pancreatic cancer.
- To evaluate the quality of life of patients before and after either chemotherapy or chemotherapy and SBRT.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Phase III Study Evaluating Modified FOLFIRINOX (mFFX) With or Without Stereotactic Body Radiotherapy (SBRT) in the Treatment of Locally Advanced Pancreatic Cancer |
Actual Study Start Date : | August 14, 2013 |
Actual Primary Completion Date : | September 30, 2021 |
Estimated Study Completion Date : | September 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: mFFX
mFOLFIRINOX
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Drug: Oxaliplatin Drug: Irinotecan Drug: Leucovorin Drug: 5FU |
Experimental: mFFX+SBRT
mFOLFIRINOX + SBRT
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Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU |
- difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT [ Time Frame: one year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the pancreas.
- Induction mFolfirinox up to 4 cycles. Informed consent must be signed by the end of the second cycle.
- Stable or better disease on re-staging scans.
- Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
- Typically, pancreatic tumors must be less than 8.0 cm in greatest axial dimension at the time of treatment planning but final determination of eligibility will be based upon satisfying the radiation normal tissue constraints as per protocol.
- ECOG 0, 1, or 2
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Patients must have acceptable organ and marrow function as defined below and within 30 days of eligibility confirmation:
- leukocytes (WBC) >=3,000/mL
- absolute neutrophil count (ANC)>=1,500mL
- platelets >=50,000/mL
- total bilirubin < or = 1.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) < or =2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- Ability to understand and the willingness to sign an informed consent form.
- Life expectancy > 6 months.
Exclusion Criteria:
- Metastatic disease
- Patients who have had prior radiotherapy to the upper abdomen/liver.
- Patients who have received chemotherapy for pancreatic cancer, other than up to 4 cycles of mFolfirinox.
- Children are excluded because pancreatic tumors rarely occur in this age group. Furthermore, treatment requires a great deal of patient cooperation including the ability to lie still for several hours in an isolated room.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (or infections requiring systemic antibiotic treatment), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix. Patients with a previous malignancy without evidence of disease for > 5 years will be allowed to enter the trial.
- Pregnant and breastfeeding women are excluded; as well as women of child-bearing potential who are unwilling or unable to use an acceptable method of birth control (hormonal or barrier method of birth control; abstinence) to avoid pregnancy for the duration of the study. Male subjects must also agree to use effective contraception for the same period as above. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Women who are not post-menopausal (as defined in Appendix III) and have a positive urine or serum pregnancy test or refuse to take a pregnancy test

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01926197
United States, California | |
UCLA | |
Los Angeles, California, United States, 60153 | |
UCSF | |
San Francisco, California, United States, 94143 | |
Stanford University, School of Medicine | |
Stanford, California, United States, 94305 | |
United States, Illinois | |
Loyola University | |
Maywood, Illinois, United States, 60153 | |
United States, South Carolina | |
Medical University of South Carolina | |
Charleston, South Carolina, United States, 29425 | |
United States, Texas | |
University of Texas Southwestern Medical Center | |
Dallas, Texas, United States, 75390 | |
United States, Washington | |
Swedish Cancer Institute | |
Seattle, Washington, United States, 98107 | |
Canada, British Columbia | |
BC Cancer Agency | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, Ontario | |
Princess Margaret Cancer Centre | |
Toronto, Ontario, Canada |
Principal Investigator: | Daniel T Chang | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT01926197 |
Other Study ID Numbers: |
IRB-27492 PANC0015 ( Other Identifier: OnCore ) NCI-2013-01658 ( Other Identifier: NCI ) |
First Posted: | August 20, 2013 Key Record Dates |
Last Update Posted: | June 14, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Leucovorin Oxaliplatin Irinotecan |
Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antidotes Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients |