Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
Primary Objective:
To determine progression free survival for mFFX +/- SBRT.
Secondary Objectives:
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA
EXCLUSION CRITERIA
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:
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
Primary purpose
Allocation
Interventional model
Masking
27 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal