A Phase II Study of Locally Advanced Pancreatic Cancer

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Brief Title

A Phase II Study of Locally Advanced Pancreatic Cancer

Official Title

A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer

Brief Summary

      The primary end point is to evaluate the 9-month progression free survival rate and safety
      profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent
      chemoradiotherapy in locally advanced pancreatic cancer.

      The secondary end points are to evaluate the disease control rate, overall survival time,
      toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy
      as well as the disease control rate after inductional chemotherapy alone in locally advanced
      pancreatic cancer. Translational research including pharmacogenomic study and biomarker study
      will also be done concomitantly.
    

Detailed Description

      Patients should be randomized to two study arms stratified by resectability status
      (borderline resectable and unresectable) after enrollment. Eligible patients will be randomly
      assigned on a 1:1 basis to either of two study groups, using a central randomization
      procedure with stratification according to NCCN criteria of resectability.

      After randomization, induction chemotherapy (ICT) will be administered for 3 cycles (3
      months). Patients who have radiological evidence of distant dissemination will be shifted to
      salvage chemotherapy. Patients who have responsive, stable disease as well as those with
      localized progressive disease after ICT will receive concurrent chemoradiotherapy (CCRT) 3-4
      weeks after the last dose of ICT. Surgical evaluation will be performed 4-6 weeks after the
      completion of CCRT. Patients who have respectable disease will undergo surgical resection.
      Postoperative adjuvant chemotherapy for 3 cycles (3 months) will be given for those who are
      considered to have curative resection. Patients who still have unresectable disease or
      non-curative resection will receive systemic chemotherapy till disease progression or
      unacceptable toxicity.

      For Arm 1, ICT with FOLFIRINOX ( oxaliplatin 85mg/m2 for 2 hr, irinotecan 180mg/m2 for 90 min
      and 5FU 3000mg/m2 + LV 150mg/m2 continuous infusion 48 hr) will be administered biweekly. For
      Arm 2, ICT with GOFL ( 800mg/m2 gemcitabine at a fixed rate of 10mg/m2/min followed by a
      2-hour oxaliplatin 85mg/m2 and then a 48-hour 3000mg/m2 5-FU and 150 mg/m2 leucovorin on day
      1 and 15 every 28 days/cycle) will be given biweekly.

      After three 3 cycles of ICT, patients without distant metastasis will be given CCRT with 5-FU
      450mg/m2 in Arm 1, gemcitabine 400mg/m2 in Arm 2, 2 hrs before RT on day1,8,15,22,29,36.
      Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.

      If complete surgical resection is feasible, optimal surgery will be performed 4-6 weeks after
      CCRT. If complete surgical resection is impossible, biopsy with or without bypass surgery may
      be performed. Patients who have curative surgical resection will receive additional 6 cycles
      ( 6 months) of adjuvant chemotherapy ( Arm1, FOLFIRINOX, Arm 2, GOFL) within 4 weeks after
      surgery and then followed up until tumor progression. Patients who are not feasible for
      curative resection, will receive continued chemotherapy (Arm1, FOLFIRINOX; Arm2, GOFL) 3-4
      weeks after CCRT complete. The regimen will continue till disease progression.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

the response rate, disease control rate, overall survival, and patients' quality of life.


Condition

Pancreatic Cancer

Intervention

ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT

Study Arms / Comparison Groups

 ICT of oxaliplatin,irinotecan,5-FU and leucovorinon and CCRT
Description:  Arm1:oxaliplatin,irinotecan,5-FU and leucovorinon D1,15 every 28days for 3 cycles,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

86

Start Date

June 2013

Completion Date

May 2019

Primary Completion Date

May 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed adenocarcinoma of the
             exocrine pancreas.

          2. Patients must have locally advanced pancreatic cancer (LAPC).

          3. Patients must have LAPC evaluated by radiologist and/or surgeon according to either
             abdominal CT or MRI, or intra-operative findings.

               -  Locally advanced unresectable disease was defined by CT or MRI images as
                  low-density tumor (primary and/or lymphadenopathy) with

                    1. extension to the celiac axis or superior mesenteric artery,

                    2. occlusion of the superior mesenteric-portal venous confluence

                    3. aortic, inferior vena cava (IVC) invasion or encasement

                    4. invasion of SMV below transverse mesocolon or unresectable after surgical
                       exploration.

             Those who had superior mesenteric vein impingement, superior mesenteric artery
             abutment were defined as borderline resectable.

             Those who had superior mesenteric vein occlusion, superior mesenteric artery
             encasement were defined as unresectable.

          4. Patients must have measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >20
             mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for
             the evaluation of measurable disease.

          5. Age >20 years and ≦70 years.

          6. ECOG performance score of 0 or 1; see Appendix A.

          7. Patients must have normal organ and marrow function as defined below:

               -  absolute neutrophil count >1,500/mL

               -  platelets >100,000/mL

               -  total bilirubin <1.5X institutional upper limit of normal

               -  ALT(SGPT) <5 X institutional upper limit of normal

               -  creatinine within normal institutional limits or creatinine clearance>60
                  mL/min/1.73 m2 for patients with creatinine levels above institutional normal

          8. Patients who present with jaundice will be allowed to enroll after control with
             temporary or permanent internal/external drainage.

          9. The effects of study agents on the developing human fetus at the recommended
             therapeutic dose are unknown. Women of child-bearing potential and men must agree to
             use adequate contraception (hormonal or barrier method of birth control; abstinence)
             prior to study entry and for the duration of study participation. Should a woman
             become pregnant or suspect she is pregnant while participating in this study, she
             should inform her treating physician immediately.

         10. Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          1. Patients with distant metastases are not eligible.

          2. Patients with endocrine or acinar pancreatic carcinoma.

          3. Patients may be receiving any steroid, immunologic or other investigational agents
             within 4 weeks prior to enrollment.

          4. Patients who have had prior chemotherapy or radiotherapy are not eligible.

          5. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to study agents used in the study.

          6. Patients who have above grade II peripheral neuropathy.

          7. Patients who had non-curable second primary malignancy within five years, except for
             non-melanoma skin cancer.

          8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          9. Pregnant women are excluded from this study because the study agents has the potential
             for teratogenic or abortifacient effects. Because there is an unknown but potential
             risk for adverse events in nursing infants secondary to treatment of the mother with
             study agents, breastfeeding should be discontinued if the mother is treated with the
             study agents.

         10. Those who are immuno-compromised or receiving immuno-suppressive therapy are excluded
             from the study because of increased risk of lethal infections and possible
             pharmacokinetic interactions with study agent administered during the study.

         11. Those who have chronic diarrhea.
      

Gender

All

Ages

20 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Yen-Shen Shen, M.D., , 



Administrative Informations


NCT ID

NCT01867892

Organization ID

T2212


Responsible Party

Sponsor

Study Sponsor

National Health Research Institutes, Taiwan

Collaborators

 National Taiwan University Hospital

Study Sponsor

Yen-Shen Shen, M.D., Principal Investigator, National Cheng-Kung University Hospital


Verification Date

May 2013