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Trial record 31 of 267 for:    Pancreatic Cancer AND Resectable

Sequential Use of AG and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03750669
Recruitment Status : Recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend Nab-paclitaxel, Gemcitabine and modified Folfirinox as the first-line chemotherapeutic regimen. Studies have shown that sequential chemotherapeutic regimen can effectively delay the drug resistance and improve the effect of chemotherapy. Here investigators intend to assess the effect of sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox as neoadjuvant chemotherapy for resectable pancreatic adenocarcinoma.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Resectable Neoadjuvant Chemotherapy Drug: AG regimen Drug: mFolfirinox Phase 2

Detailed Description:
Investigators chose resectable pancreatic adenocarcinoma patients. The planned treatment was given to the participants after randomization. Tumor size, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the sequential treatment with Nab-paclitaxel plus Gemcitabine and modified Folfirinox could or couldn't benefit the prognosis of resectable pancreatic adenocarcinoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sequential Use of Nab-paclitaxel Plus Gemcitabine and mFOLFIRINOX as Neoadjuvant Chemotherapy for Resectable Pancreatic Cancer: A Randomized Control Study
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 20, 2023
Estimated Study Completion Date : October 20, 2024


Arm Intervention/treatment
Experimental: Neoadjuvant Chemotherapy
Patients receive the sequential neoadjuvant chemotherapy of AG regimen (nab-paclitaxel plus gemcitabine) and mFOLFIRINOX before resection.
Drug: AG regimen
Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2
Other Name: Nab-paclitaxel and Gemcitabine

Drug: mFolfirinox
Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
Other Name: Folic acid, 5- fluorouracil, irinotecan and oxaliplatin

No Intervention: control
Patients receive surgical treatment without any neoadjuvant treatments.



Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: Up to approximately 60 months ]
    The time of initial response until documented tumor recurrence.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to approximately 60 months ]
    The time of initial response until documented patient death

  2. Objective response rate [ Time Frame: Up to approximately 60 months ]
    The proportion of patients with tumor size reduction of a predefined amount and for a minimum time period

  3. Carbohydrate antigen 19-9 [ Time Frame: Up to approximately 60 months ]
    Serum Carbohydrate antigen 19-9 level

  4. EORTC QLQ - PAN26 score [ Time Frame: Up to approximately 60 months ]
    QLQ score assessed by the European Organization for Research and Treatment of Cancer Quality of Life scale for pancreatic cancer (EORTC QLQ - PAN26. For details: PMID 10533475.)

  5. Serious adverse events incidence [ Time Frame: Up to approximately 60 months ]
    The proportion of patients with grade 3/4 adverse events



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) confirmed pancreatic ductal adenocarcinoma (PDAC).
  • No evidence of distant metastasis (such as liver, peritoneum, lung) evaluated by abdominal contrast-enhanced CT, MRI, and chest CT. PET/CT or other imaging examinations would be used if necessary.
  • Initial assessment for definitive resectable tumors (resectability judgment is based on CT enhanced scan or magnetic resonance imaging, NCCN2018 first edition standard).
  • ECOG score 0 or 1.
  • Serum creatinine level is normal, and serum total bilirubin level is less than 1.5 x ULN.
  • ALT and AST are less than 2 x ULN.
  • If biliary obstruction is observed, biliary decompression should be performed when the patient is randomly assigned to receive neoadjuvant chemotherapy.
  • Leukocyte count (> 3.5 x 10^6 /mL), neutrophil count (> 1.5 x 10^6 /mL), platelet count (> 80 x 10^6 /mL), hemoglobin (> 9 g/dL).
  • Signed informed consent.

Exclusion Criteria:

  • History of malignance treatment in the past, excluding basal and cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma
  • Tumor is a local recurrent lesion.
  • Imaging confirmed severe portal hypertension / cavernous transformation.
  • Ascites
  • Gastric outlet obstruction
  • Respiratory failure requires supplementation of oxygen.
  • Immune deficiency syndrome, such as active tuberculosis and HIV infection.
  • Hematological precancerous diseases, such as myelodysplastic syndromes.
  • Major cardiovascular diseases (including myocardial infarction, unstable angina, congestive heart failure, severe uncontrolled arrhythmia) during the past six months of enrollment.
  • Evidence of clinical-related or previous interstitial lung disease, such as noninfectious pneumonia or pulmonary fibrosis, or baseline chest CT scan or chest X-ray findings
  • Previous or physical findings of central nervous system disease, except for adequately treated (e.g. primary brain tumors, uncontrolled seizures or strokes with standard medications)
  • Preexisting neuropathy > 1 (NCI CTCAE).
  • Allograft requires immunosuppressive therapy or other major immunosuppressive therapies.
  • Severe serious wounds, ulcers or fractures.
  • Confirmed coagulant disease.
  • Clinical evaluation is unacceptable.

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): NCT03750669


Contacts
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Contact: Tingbo Liang, MD PhD 8613666676128 liangtingbo@zju.edu.cn
Contact: Qi Zhang, MD 8613819137113 zhangqi86@gmail.com

Locations
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China, Zhejiang
The second affiliated hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Qi Zhang, MD    8613819137113    zhangqi86@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Tingbo Liang, MD PhD Department of HBP Surgery, SAHZJU

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Responsible Party: Liang Tingbo, Director of HBP Surgery, The Second Affiliated Hospital Zhejiang University School of Medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03750669     History of Changes
Other Study ID Numbers: CISPD-1
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liang Tingbo, Second Affiliated Hospital, School of Medicine, Zhejiang University:
Pancreatic Cancer
Pancreatic Adenocarcinoma
Gemcitabine
Nab-paclitaxel
Modified Folfirinox
Sequential treatment
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases
Folic Acid
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Oxaliplatin
Irinotecan
Fluorouracil
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors