Phase 3 Study of FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer

NCT01926197 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: IRB-27492PANC0015NCI-2013-01658
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 9

Brief Summary

The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.

  38 months

Secondary Outcomes (5)

• Local Progression-free Survival (Local PFS)

  38 months

• Progression-free Survival (PFS) at 1 Year

  1 year

• Metastasis-free Survival (MFS)

  62 months

• Overall Survival (OS)

  62 months

• Grade 2 or Greater Gastrointestinal (GI) Toxicity

  3 months

Study Arms (2)

Modified FOLFIRINOX

ACTIVE COMPARATOR

Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin.

Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU

Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

EXPERIMENTAL

Modified FOLFIRINOX (mFFX), a chemotherapeutic treatment regimen of 5FU, leucovorin, irinotecan, and oxaliplatin, in combination with stereotactic body radiotherapy (SBRT)

Drug: Oxaliplatin; Drug: Irinotecan; Drug: Leucovorin; Drug: 5FU; Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Oxaliplatin DRUG

Oxaliplatin 85 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

Also known as: Eloxatin

Modified FOLFIRINOX; Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

Irinotecan DRUG

Irinotecan 180 mg/m² IV over 90 minutes on Day 1 of a 14-day cycle.

Also known as: Camptosar, Camptothecin-11 (CPT-11), Campto, Onivyde

Modified FOLFIRINOX; Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

Leucovorin DRUG

Leucovorin 400 mg/m² IV over 2 hours on Day 1 of a 14-day cycle.

Also known as: Folinic acid, Wellcovorin, Citrovorum Factor

Modified FOLFIRINOX; Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

5FU DRUG

5FU 2,400 mg/m² IV over 46 to 48 hours starting on Day 1 of a 14-day cycle.

Also known as: 5-fluorouracil, Tolak, Fluoroplex, Efudex, Carac, Adrucil

Modified FOLFIRINOX; Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy (SBRT) RADIATION

Radiotherapy treatment starting about 8 weeks after modified FOLFIRINOX induction chemotherapy, administered as 5 fractions of 8 Grey (Gy) each, on 5 separate days.

Modified FOLFIRINOX plus Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed adenocarcinoma of the pancreas
• Determined unresectable by a pancreatic cancer surgeon or a multi-disciplinary or gastrointestinal oncology Tumor Board.
• Stable or better disease on re-staging scans
• Typically, tumors \< 8.0 cm in greatest axial dimension but final determination of eligibility based upon radiation normal tissue constraints
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
• Leukocytes (white blood cells, WBC) ≥ 3,000/mL
• Absolute neutrophil count (ANC) ≥ 1,500/mL
• Platelets ≥ 50,000/mL
• Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 2.5 X institutional ULN
• Creatinine within normal institutional limits
• Ability to understand and the willingness to sign an informed consent form
• Life expectancy \> 6 months

You may not qualify if:

• Metastatic disease
• Prior radiotherapy to the upper abdomen/liver.
• Prior chemotherapy for pancreatic cancer, other than up to 4 cycles of modified FOLFIRINOX.
• Age \< 18 years
• 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
• 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 or lactating
• 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) for duration of the study
• 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
• Male subjects who are unwilling or unable to use effective contraception for duration of the study

Sponsors & Collaborators

• Stanford University: lead

Study Sites (9)

UCLA

Los Angeles, California, 60153, United States

Location

UCSF

San Francisco, California, 94143, United States

Location

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98107, United States

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Oxaliplatin; Irinotecan; irinotecan sucrosofate; Leucovorin; Fluorouracil; Radiosurgery

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Samantha Wong
• Organization: Stanford Medicine at Stanford University

swong8@stanford.edu

650-498-8495

Study Officials

• Daniel T Chang

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 20, 2013
• Study Start: August 14, 2013
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2022
• Last Updated: October 28, 2022
• Results First Posted: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); CA (2)