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Trial record 14 of 857 for:    Pancreatic Cancer AND Progression-free survival

SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer (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.
 
ClinicalTrials.gov Identifier: NCT03443492
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2018
Last Update Posted : August 22, 2019
Sponsor:
Collaborators:
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
Taipei Medical University Shuang Ho Hospital
Chang Gung Memorial Hospital
Tri-Service General Hospital
E-DA Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

Brief Summary:
A Phase II Randomized Study.Primary objective:to investigate the 6-month progression-free survival (PFS) rate i patients receiving SLOG or mFLFIRINOX as a first-line treatment for locally advanced and metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Pancreatic Cancer Drug: S-1 Drug: Leucovorin(oral ) Drug: Gemcitabine Drug: Oxaliplatin Drug: Irinotecan Drug: 5-FU Drug: Leucovorin(IV) Phase 2

Detailed Description:
A total of 130 patients (65patients in each arm) will be calculated, based on the assumption of a 6-month PFS rate of 45% with mFOLFIRINOX vs 60% wuth SLOG, to achieve 75% power, with a drop-out rate of 10%. Two-sided test was performed with type I error=0.10.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Study of SLOG vs mFOLFIRINOX as the First-line Treatment in Locally Advanced Uncresectable or Metastatic Pancreatic Cancer
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SLOG
800 mg/m2 gemcitabine at a fixed rate of 10 mg/m2/min followed by a 2-hour intravenous infusion of oxaliplatin on day 1 plus twice daily oral S-1 80-120 mg/day (based on BSA) and oral leucovorin 30 mg twice a day on day 1 to day 7, every 14 days as a cycle
Drug: S-1
Intervention is administered to patients in this Arm.

Drug: Leucovorin(oral )
Intervention is administered to patients in this Arm.

Drug: Gemcitabine
Intervention is administered to patients in this Arm.

Drug: Oxaliplatin
Intervention is administered to patients in this Arm.

Experimental: mFOLFIRINOX
oxaliplatin at a dose of 85 mg/m2, given as a 2-hour infusion, with the addition, after 30 minutes, of irinotecan at a dose of 150 mg/m2, given as a 90-minute infusion. The treatment was immediately followed by a continuous intravenous infusion via central venous catheter of leucovorin 400 mg/m2 given as a 2-hour infusion and 5-FU 2400 mg/m2 over a 46-hour period on day 1 every 14 days/cycle.
Drug: Oxaliplatin
Intervention is administered to patients in this Arm.

Drug: Irinotecan
Intervention is administered to patients in this Arm.

Drug: 5-FU
Intervention is administered to patients in this Arm.

Drug: Leucovorin(IV)
Intervention is administered to patients in this Arm.




Primary Outcome Measures :
  1. progression free survival (PFS) [ Time Frame: Since this is an exploratory trial, it takes a sample size of 61 patients per arm entered in 2 years with a minimum 1 year of follow up to reach 75% power with type I error of 10% under the assumptions of exponential survival functions. ]
    The 6-month PFS rates of the two arms are assumed to be 60% (SLOG) vs. 45% (mFOLFIRINOX)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have cyto-/histologically confirmed, locally advanced unresectable or metastatic adenocarcinoma of the pancreas (mPAC). Patients who have disease measurable or evaluable on x-ray, CT scan, or physical examination are eligible.
  2. Patients must have no history of prior chemotherapy for PAC, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
  3. Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
  4. Patients' baseline ECOG performance status must be 1.
  5. Patients' life expectancy 12 weeks or greater.
  6. Patients' age 20 and 80.
  7. Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
  8. Patients must agree to have indwelling venous catheter implanted.
  9. Women or men and their partners of reproductive potential should agree to use an effective contraceptive method.
  10. All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

Exclusion Criteria:

  1. Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy.
  2. Patients with central nervous system metastasis
  3. Patients with active infection
  4. Pregnant or breast-nursing women
  5. Patients with active cardiopulmonary disease or history of ischemic heart disease
  6. Patients who have peripheral neuropathy > Grade I of any etiology
  7. Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
  8. Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment
  9. Patients who are under biologic treatment for their malignancy
  10. Laboratory tests (hematology, chemistry) outside specified limits:

    1. WBC ≤ 3 x 10³/mm³
    2. ANC ≤ 1.5 x 10³/mm³
    3. Platelets ≤ 100.000/mm³
    4. Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l)
    5. GFR < 60 mL/min
    6. AST and/or ALT > 2.5 x ULN; for patients with significant liver metastasis AST and/or ALT > 5 x ULN
    7. Total bilirubin > 2 x ULN
    8. Albumin < 2.5 g/dL

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): NCT03443492


Locations
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Taiwan
National Institute of Cancer Research
Miaoli, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
China Medical University Hospital
National Cheng-Kung University Hospital
Kaohsiung Medical University
Taipei Medical University Shuang Ho Hospital
Chang Gung Memorial Hospital
Tri-Service General Hospital
E-DA Hospital
Investigators
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Study Chair: Chen Li-Tzong National Insitute of Cancer Research

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Responsible Party: National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier: NCT03443492     History of Changes
Other Study ID Numbers: T5217
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Irinotecan
Antimetabolites, Antineoplastic
Antimetabolites
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