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CompletedNCT01560949Updated Aug 10, 2020Results posted

Preoperative Folfirinox, Radiation Therapy for Resectable Adenocarcinoma of the Pancreas

A Phase 2 interventional study of Oxaliplatin and Irinotecan in Pancreatic Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-10.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Study Drug Administration:

You will receive up to 3 phases of study therapy: the systemic chemotherapy phase, the chemoradiation phase, and surgery, if possible.

During the systemic chemotherapy phase, you will receive mFolfirinox 1 time every 2 weeks (Weeks 1, 3, 5, 7, 9 and 11) for 12 weeks. You will receive oxaliplatin by vein over a 2-hour period. After receiving oxaliplatin, you will receive irinotecan by vein over a 90-minute period. After receiving irinotecan, you will then receive 5-FU through a portable pump for the next 46 hours. You will take the portable pump home with you and will receive instructions on how to use it.

You will begin receiving chemoradiation within 6 weeks after you have finished receiving the Week 11 dose of mFolfirinox. However, you will not begin receiving it until you have recovered from side effects of the chemotherapy.

During the chemoradiation phase, you will receive gemcitabine over about 35 minutes 1 time each week for 5 weeks. You will also receive radiation therapy 5 days a week (Monday through Friday) for 5 1/2 weeks (a total of 28 treatments). If you miss any of the days of radiation, they will be made up at the end of treatment so that you will receive the full amount of radiation. You will be given a separate consent form that explains the radiation procedure and the risks it may present.

After the chemoradiation phase, you will not receive any treatment for 4-6 weeks so your body can recover. If after this time the disease has not gotten worse or spread to other parts of the body, you will have surgery to try to remove the tumor. You will be given a separate consent form for the surgery that describes how it is performed and its risks.

If the disease has gotten worse or spread to other parts of the body, you will not be able to have surgery. The study doctor will discuss other therapy options with you.

Study Visits:

At Weeks 1, 3, 5, 7, 9, and 11 of the systemic chemotherapy phase:

  • You will have a physical exam, including measurement of your weight and vital signs (blood pressure and heart rate).
  • Blood (about 3 tablespoons) will be drawn for routine tests.

Within 4 weeks before beginning the chemoradiation phase:

  • You will have CT or MRI scans to check the status of the disease.
  • Blood (about 1 tablespoon) will be drawn for tumor marker testing.

At Weeks 1, 2, 3, 4, 5, and 6 of the chemoradiation phase:

  • You will have a physical exam, including measurement of your weight and vital signs.
  • Blood (about 2-3 tablespoons) will be collected for routine tests. At Week 6, an additional 2 teaspoons of blood will be drawn for CTC testing.

About 4 to 6 weeks after you complete the chemoradiation phase:

  • Blood (about 1 tablespoon) will be drawn for tumor marker testing.
  • You will have CT or MRI scans to check the status of the disease.

If you are eligible to have surgery after the chemoradiation phase, the following tests and procedures will also be performed:

  • Blood (about 4 teaspoons total) will be drawn within 2 weeks before surgery for CTC testing. Blood will also be collected during surgery, if the surgeon thinks it is safe and feasible.
  • Tumor tissue collected during a previous procedure will be used for biomarker testing. An additional sample of tumor tissue will be collected from the tissue removed during surgery and used for biomarker testing. Biomarkers are found in the blood/tissue and may be related to your reaction to the study drug.

Length of Study:

You will receive study treatment over the course of up to 30 weeks. You will be taken off study if the disease gets worse, the study doctor thinks it is in your best interest, or if you do not follow the study directions.

You may choose to stop receiving the study treatment at any time. If you choose to stop, you should tell the study doctor or a member of the staff right away. They will make sure that proper procedures are followed and a final visit will be scheduled for your safety.

Follow-up:

Blood (about 2 teaspoons) will be collected for CTC testing 2-3 months after your surgery, if you were one of the first 30 participants enrolled in the study.

You will have a CT or MRI scan of the abdomen and pelvis every 4 months for 2 years to check the status of the disease.

This is an investigational study. 5-FU, oxaliplatin, irinotecan, and gemcitabine are each FDA approved and commercially available to treat different types of cancer:

  • 5-FU: pancreatic, gastric, breast, colon/rectum, and skin cancer (basal cell carcinoma)
  • Oxaliplatin: colon and rectal cancer
  • Irinotecan: colorectal cancer
  • Gemcitabine: pancreatic, lung, ovarian, and breast cancer.

The use of these 4 drugs together and in combination with radiation therapy for the treatment of pancreatic cancer is investigational.

Up to 33 patients will be enrolled in this study. All will be enrolled at MD Anderson.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Pancreatic Cancer
  • Adenocarcinoma of the Pancreas
  • High Risk Resectable
  • Borderline Resectable
  • Chemotherapy
  • Chemoradiation therapy
  • Oxaliplatin
  • Eloxatin
  • Irinotecan
  • CPT-11
  • Camptosar
  • 5-FU
  • 5-Fluorouracil
  • Adrucil
  • Efudex
  • Gemcitabine
  • Gemcitabine Hydrochloride
  • Gemzar
  • Radiation Therapy
  • XRT
  • RT
  • External Beam Radiation Therapy
03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's enrollment of 34 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • 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 · Drug: Irinotecan · Drug: 5-FU · Drug: Gemcitabine · Radiation: Radiation Therapy

Interventions

  • DrugOxaliplatin

    75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.

    Also known as: Eloxatin

  • DrugIrinotecan

    150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.

    Also known as: CPT-11, Camptosar

  • Drug5-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.

    Also known as: 5-Fluorouracil, Adrucil, Efudex

  • DrugGemcitabine

    350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).

    Also known as: Gemcitabine Hydrochloride, Gemzar

  • RadiationRadiation 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).

    Also known as: XRT, RT

06

What researchers measure

Primary outcomes

  1. Number of Participants With Resectability Rate

    Patients with borderline resectable treated with preoperative modified FOLFIRINOX chemotherapy, followed by gemcitabine-based chemoradiation therapy. At least 4- 6 weeks after the last dose of gemcitabine if there is no local progression or distant metastasis, patients were scheduled for surgery.

    Time frame: 43 months

Secondary outcomes

  1. Number of Participants With R0 Margin Resection

    The specimen was designated R0 if no tumor cells were identified at any of the resection margins.

    Time frame: 43 months

  2. Disease Free Survival (DFS)

    Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence.

    Time frame: 54 months

  3. Number of Participants That Were SMAD4 Positive Before and After Surgery

    Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation.

    Time frame: 43 months

  4. Overall Survival

    Overall survival (OS) was defined as the time interval from the date of diagnosis to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method.

    Time frame: 54 months

  5. Number of Participants With Local and Distant Failure

    Time frame: 43 months

  6. Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Pre-Surgery

    Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation.

    Time frame: 43 months

  7. Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Post-Surgery

    Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation.

    Time frame: 43 months

07

Results

Posted Aug 10, 2020

Participant flow

June 2012 to November 2015. All recruitment done at The University of Texas, MD Anderson Cancer Center.

Systemic Phase: mFOLFIRINOX
Participant flow — Systemic Phase: mFOLFIRINOX
MilestoneSystemic Phase: mFOLFIRINOX
Started33
Completed27
Not completed6
Withdrew: Adverse event6
Chemoradiation Phase: With Gemcitabine
Participant flow — Chemoradiation Phase: With Gemcitabine
MilestoneSystemic Phase: mFOLFIRINOX
Started23
Completed23
Not completed0
Surgery Phase
Participant flow — Surgery Phase
MilestoneSystemic Phase: mFOLFIRINOX
Started18
Completed15
Not completed3
Withdrew: Physician decision3

Outcome measures

PrimaryNumber of Participants With Resectability Rate

Patients with borderline resectable treated with preoperative modified FOLFIRINOX chemotherapy, followed by gemcitabine-based chemoradiation therapy. At least 4- 6 weeks after the last dose of gemcitabine if there is no local progression or distant metastasis, patients were scheduled for surgery.

Time frame:
43 months
Reported as:
Count of participants · Participants
Number of Participants With Resectability Rate
ParticipantsSurgery
Number of Participants With Resectability Rate15
SecondaryNumber of Participants With R0 Margin Resection

The specimen was designated R0 if no tumor cells were identified at any of the resection margins.

Time frame:
43 months
Reported as:
Count of participants · Participants
Number of Participants With R0 Margin Resection
ParticipantsSurgery
Number of Participants With R0 Margin Resection10
SecondaryDisease Free Survival (DFS)

Disease free survival (DFS) was defined as the time interval from the date of surgery to the date of disease recurrence or death or the date of a participant was last known to be alive without disease recurrence.

Time frame:
54 months
Reported as:
Median · months
Disease Free Survival (DFS)
monthsAll Phases
Disease Free Survival (DFS)11.1 (5.8 to NA)
SecondaryNumber of Participants That Were SMAD4 Positive Before and After Surgery

Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation.

Time frame:
43 months
Reported as:
Count of participants · Participants
Number of Participants That Were SMAD4 Positive Before and After Surgery
ParticipantsSurgery
SMAD4 positive before surgery4
SMAD4 positive after surgery4
SecondaryOverall Survival

Overall survival (OS) was defined as the time interval from the date of diagnosis to the date of death due to any cause or the date a patient was last known to be alive. Estimated by using the Kaplan-Meier method.

Time frame:
54 months
Reported as:
Median · months
Overall Survival
monthsAll Phases(Systematic,Chemoradiation w/ Gemcitabine & Surgery)
Overall Survival24 (16.2 to 29.6)
SecondaryNumber of Participants With Local and Distant Failure
Time frame:
43 months
Reported as:
Count of participants · Participants
Number of Participants With Local and Distant Failure
ParticipantsSurgery
Local recurrence0
Distant recurrence10
SecondaryNumber of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Pre-Surgery

Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation.

Time frame:
43 months
Reported as:
Count of participants · Participants
Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Pre-Surgery
ParticipantsSurgery
Present4
Absent2
SecondaryNumber of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Post-Surgery

Tumor tissue collected pre-therapy and post-therapy for surgically resected patients was assessed for SMAD4 status and classified as either present or absent based on immunohistochemistry evaluation.

Time frame:
43 months
Reported as:
Count of participants · Participants
Number of Participants Correlative Studies Including DPC4 (SMAD4) Staining and Circulating Tumor Cells (CTC) Post-Surgery
ParticipantsSurgery
Present4
Absent7

Adverse events

Collected over 4 years,6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Systemin Phase: mFOLFIRINOX0/33 (0%)5/33 (15.2%)33/33 (100%)
Chemoradiation Phase: Radiation With Gemcitabine0/23 (0%)2/23 (8.7%)23/23 (100%)
Surgery0/18 (0%)0/18 (0%)5/18 (27.8%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventSystemin Phase: mFOLFIRINOXChemoradiation Phase: Radiation With GemcitabineSurgery
DizzinessNervous system disorders2/330/230/18
Duodenal hemorrhageGastrointestinal disorders0/331/230/18
Duodenal ulcerGastrointestinal disorders0/331/230/18
Gastric ulcerGastrointestinal disorders0/331/230/18
NauseaGastrointestinal disorders0/331/230/18
Gastro-esophageal hemorrhageGastrointestinal disorders0/331/230/18
Multi-organ failure (Septic shock)General disorders1/330/230/18
Neutrophil count decreasedInvestigations1/330/230/18
DehydrationMetabolism and nutrition disorders1/330/230/18
DyspneaRespiratory, thoracic and mediastinal disorders1/330/230/18
Most frequent other events
Showing 10 of 31
Most frequent other events
EventSystemin Phase: mFOLFIRINOXChemoradiation Phase: Radiation With GemcitabineSurgery
FatigueGeneral disorders28/3318/231/18
Platelet countInvestigations11/3318/230/18
NauseaGastrointestinal disorders25/3315/230/18
DiarrheaGastrointestinal disorders20/335/230/18
DysesthesiaNervous system disorders18/330/230/18
AnorexiaGastrointestinal disorders18/3310/231/18
Neutrophil count decreasedInvestigations10/3310/230/18
Alanine aminotransferase increasedInvestigations13/334/230/18
ParesthesiaNervous system disorders13/332/230/18
Abdominal cramping/painGastrointestinal disorders13/337/230/18

Baseline characteristics

A total of 34 participants enrolled in study 1 participant withdrew consent prior to receiving treatment.

Age, Categorical
Age, Categorical(Participants)Systemic Phase: mFOLFIRINOX
<=18 years0
Between 18 and 65 years18
>=65 years15
Sex: Female, Male
Sex: Female, Male(Participants)Systemic Phase: mFOLFIRINOX
Female12
Male21
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Systemic Phase: mFOLFIRINOX
Hispanic or Latino3
Not Hispanic or Latino30
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Systemic Phase: mFOLFIRINOX
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American2
White26
More than one race0
Unknown or Not Reported3
Region of Enrollment
Region of Enrollment(participants)Systemic Phase: mFOLFIRINOX
United States33
08

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 5, 2013

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01560949
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Mar 22, 2012
Start date
Jun 14, 2012
Primary completion
Feb 20, 2019
Completion
Feb 20, 2019
Results posted
Aug 10, 2020
Last update
Aug 10, 2020

Study contacts

Gauri Varadhachary, MD, MBBS
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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