Phase III FOLFIRINOX (mFFX) +/- SBRT in Locally Advanced Pancreatic Cancer
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01926197 |
|
Recruitment Status :
Recruiting
First Posted : August 20, 2013
Last Update Posted : March 14, 2018
|
Sponsor:
Stanford University
Information provided by (Responsible Party):
Stanford University
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| 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) |
| Estimated Enrollment : | 172 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 |
| Study Start Date : | August 2013 |
| Estimated Primary Completion Date : | September 2018 |
| Estimated Study Completion Date : | September 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: mFFX
mFOLFIRINOX
|
Drug: Oxaliplatin Drug: Irinotecan Drug: Leucovorin Drug: 5FU |
|
Experimental: mFFX+SBRT
mFOLFIRINOX + SBRT
|
Drug: Oxaliplatin Radiation: SBRT Drug: Irinotecan Drug: Leucovorin Drug: 5FU |
Primary Outcome Measures :
- difference in progression-free survival between mFOLFIRINOX alone vs. mFOLFIRINOX and SBRT [ Time Frame: one year ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
-
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
Information from the National Library of Medicine
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
Contacts
| Contact: Samantha Wong | 650-498-8495 | swong8@stanford.edu |
Locations
| United States, California | |
| UCLA | Recruiting |
| Los Angeles, California, United States, 60153 | |
| Contact: Jackie Hernandez 559-624-3015 JHernandez@mednet.ucla.edu | |
| Stanford University, School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Samantha Wong 650-498-8495 swong8@stanford.edu | |
| Principal Investigator: Daniel T Chang | |
| United States, Illinois | |
| Loyola University | Recruiting |
| Maywood, Illinois, United States, 60153 | |
| Contact: Beth Chiappetta, RN 708-216-2568 BCHIAPPETTA@lumc.edu | |
| United States, Texas | |
| University of Texas Southwestern Medical Center | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Patrick Brooks 214-645-2250 Patrick.Brooks@UTSouthwestern.edu | |
| Canada, British Columbia | |
| BC Cancer Agency | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Contact: Sonya Lam 604-877-6000 ext 6006 Sonya.Lam@bccancer.bc.ca | |
| Canada, Ontario | |
| Princess Margaret Cancer Centre | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Sonca Lengoc 416-946-4501 ext 4820 sonca.lengoc@rmp.uhn.ca | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Daniel T Chang | Stanford University |
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01926197 History of Changes |
| Other Study ID Numbers: |
PANC0015 27492 |
| First Posted: | August 20, 2013 Key Record Dates |
| Last Update Posted: | March 14, 2018 |
| Last Verified: | March 2018 |
Additional relevant MeSH terms:
|
Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases |
Oxaliplatin Irinotecan Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |