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Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas

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. Read our disclaimer for details. Identifier: NCT01560949
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : May 14, 2019
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if a chemotherapy combination called modified Folfirinox (or mFolfirinox), followed by a combination of gemcitabine and radiation therapy, followed by surgery, can help to control pancreatic cancer. The safety of this treatment will also be studied.

mFolfirinox consists of 5-FU, oxaliplatin, and irinotecan. These 3 drugs, along with gemcitabine, are each designed to block the growth of cancer cells, which may lead to cancer cell death.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Oxaliplatin Drug: Irinotecan Drug: 5-FU Drug: Gemcitabine Radiation: Radiation Therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Preoperative Systemic Chemotherapy (Modified FOLFIRINOX) Followed by Radiation Therapy for Patients With High Risk Resectable and Borderline Resectable Adenocarcinoma of the Pancreas
Actual Study Start Date : June 14, 2012
Actual Primary Completion Date : February 20, 2019
Actual Study Completion Date : February 20, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Chemotherapy + Radiation

SYSTEMIC PHASE: Chemotherapy with Oxaliplatin followed by Irinotecan followed by 5-FU. m FOLFIRINOX - oxaliplatin 75 mg/m2 d1 + irinotecan 150 mg/m2 d1 + 5-FUl 2,000 mg/m2 46h continuous infusion, every other week for 6 cycles (12 weeks).

CHEMORADIATION PHASE: This phase will start at least 2 weeks, but no more than 6 weeks after completion of the last cycle of mFOLFIRINOX. Chemoradiation with Gemcitabine: 350 mg/m2 IV over 35 minutes every week for 5 doses beginning day 1 (days 1, 8, 15, 22, 29)

Radiation: External beam radiation therapy will be delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions) to the GTV + 1.5 cm margin.

SURGERY- At least 4-6 weeks after last dose of Gemcitabine, if no local progression or distant metastasis. Patients whose scans show unequivocal local or distant progression are not candidates for surgery.

Drug: Oxaliplatin
75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
Other Name: Eloxatin

Drug: Irinotecan
150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
Other Names:
  • CPT-11
  • Camptosar

Drug: 5-FU
2000 mg/m2 by vein over 46 hour continuous infusion, on Days 1 - 2 during weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
Other Names:
  • 5-Fluorouracil
  • Adrucil
  • Efudex

Drug: Gemcitabine
350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).
Other Names:
  • Gemcitabine Hydrochloride
  • Gemzar

Radiation: Radiation Therapy
External beam radiation therapy delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy 1.8 Gy/fraction (28 fractions).
Other Names:
  • XRT
  • RT

Primary Outcome Measures :
  1. Resection Rate [ Time Frame: 12 weeks ]
    Resectability rate defined as proportion of participants who undergo surgery among all enrolled participants. The Simon's optimum two-stage design is applied in this study. Sample size of 66 is chosen to differentiate between good resectability rate of 60% and poor resectability rate of 40% with 90% power and at a significance level of 0.05. Resectability rate estimated, along with the 95% confidence interval, using intent-to-treat (ITT) principle.

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 2 months after surgery ]
    Overall survival measured from time of histologic or cytologic diagnosis of pancreatic adenocarcinoma. Kaplan-Meier method used to assess overall survival (OS), progression-free survival (PFS) and disease-free survival (DFS). Assessment of status of DPC4 (positive versus negative) preoperative and after surgery and to evaluate association between the DPC4 status and survival endpoints. CTCs also measured from blood drawn at baseline, post treatment-presurgery, during surgery and 2-3 months after surgery.

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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:

  1. Cytologic or histologic proof of adenocarcinoma of the pancreas is required prior to treatment. Patients with Islet cell tumors are not eligible.
  2. Only untreated patients with high risk pancreatic adenocarcinomas will be eligible for the study. For this study, such patients are defined as those who meet one or more of the following radiographic or serologic criteria: a)Primary tumor that involves the superior mesenteric vein causing a vein deformity or segmental venous occlusion with a patent vessel above and below suitable for reconstruction. b)Primary tumor that involves </= 180 degrees of the superior mesenteric artery (SMA), celiac axis or any of its branches on CT or MRI. c) Primary tumor that abuts or encases (>/= 50% of the vessel circumference) a short segment of the common hepatic artery (typically at the gastroduodenal artery origin)
  3. (continuation of #2). d) Patients with a high CA19-9 (=/>500mg/dl) in the presence of a bilirubin =/< 2.0 mg/dL. e) Radiographic findings consistent with malignant peripancreatic lymphadenopathy outside the planned field on CT or MRI f) Radiographic findings of indeterminate liver or peritoneal lesions on CT or MRI concerning but not diagnostic of metastatic disease.
  4. Patients cannot have known hepatic or peritoneal metastases detected by ultrasound (US), CT scan, MRI or laparotomy.
  5. There will be no upper age restriction; patients with Eastern Cooperative Oncology Group (ECOG) 0-1 are eligible.
  6. Adequate renal, and bone marrow function: a) Leukocytes >/= 3,000/uL. b) Absolute neutrophil count >/=1,500/uL.c) Platelets >/=100,000/Ul. d) Serum creatinine </= 2.0 mg/dL.
  7. Hepatic function (endoscopic or percutaneous drainage as needed). a)Total bilirubin </= 2 X institutional upper limits of normal (ULN). b) AST (SGOT)/ALT (SGPT) </= 5 X institutional ULN.
  8. Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude protocol therapy.
  9. Women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding.
  10. Patients must sign a study-specific consent form.

Exclusion Criteria:

  1. Patients whose tumors are defined as locally advanced cancer or metastatic cancer are not eligible.
  2. Unstable angina or New York Heart Association (NYHA) Grade II or greater congestive heart failure; multiple comorbidity that preclude a major abdominal surgery.
  3. Known presence of metastases.
  4. Inability to comply with study and/or follow-up procedures.
  5. Patients < 18 years of age.
  6. Pregnant women with a positive (blood B-HCG) pregnancy test are excluded from this study.
  7. Patients with an active second malignancy with the exception of non-melanoma skin cancer.

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 identifier (NCT number): NCT01560949

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Gauri Varadhachary, MD, MBBS M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01560949     History of Changes
Other Study ID Numbers: 2011-1208
NCI-2012-00571 ( Registry Identifier: NCI CTRP )
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Cancer
Adenocarcinoma of the Pancreas
High Risk Resectable
Borderline Resectable
Chemoradiation therapy
Gemcitabine Hydrochloride
Radiation Therapy
External Beam Radiation Therapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors