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Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients

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: NCT03278015
Recruitment Status : Unknown
Verified September 2017 by Dabin Xu, Chinese PLA General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Dabin Xu, Chinese PLA General Hospital

Brief Summary:
Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. the purpose of this study is to three chemotherapy regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with gemcitabine),which is best regimens for raising patients' survival rate, and will provide a chemotherapy choice for clinic therapy of pancreatic cancer.

Condition or disease Intervention/treatment Phase
Cancer of Pancreas Drug: Nab-paclitaxel plus Gemcitabine Drug: Gemcitabine monotherapy Drug: S-1 monotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : September 30, 2018


Arm Intervention/treatment
Experimental: Nab-paclitaxel plus Gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Drug: Nab-paclitaxel plus Gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Other Names:
  • nab-paclitaxel abraxane ABI-007
  • GEMXAR

Experimental: Gemcitabine monotherapy
Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Drug: Gemcitabine monotherapy
Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Other Name: GEMXAR

Experimental: S-1 monotherapy
S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
Drug: S-1 monotherapy
S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.




Primary Outcome Measures :
  1. Disease free survival(DFS) [ Time Frame: 3 years ]
    To determine the DFS of post-operative patients with pancreatic cancer

  2. overall survival time (OS) [ Time Frame: 5 years ]
    To determine the OS post-operative patients with pancreatic cancer

  3. median overall survival time (mOS) [ Time Frame: 5 years ]
    To determine the mOS post-operative patients with pancreatic cancer


Secondary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: 3 years ]
    All patients must be considered in response analysis, including those who discontinue treatment or who die for any reason prior to response evaluations

  2. Quality of Life Assessment [ Time Frame: 3 years ]
  3. safety profile [ Time Frame: 3 years ]
    Treatment-emergent adverse events, drug-related adverse events will be analysed by 3 groups

  4. Disease control rate(DCR) [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed-consent form.
  2. Man or woman aged 18 years to 80 years.
  3. Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma.
  4. Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C, <=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks.
  6. Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥ 70 x 109/L; hemoglobin ≥ 8.0 g/dL.
  7. Albumin ≥ 30 g/L.
  8. Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN); Serum total bilirubin ≤ 1.5 x ULN; Serum creatinine ≤ 1.5 x ULN.
  9. Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.
  10. Willing and able to comply with study procedures for the duration of the study.

Exclusion Criteria:

  1. Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment.
  2. Patients have active cardiac disease including any of the following:

    1. In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs.
    2. Any clinically significant abnormal ECG form, for example, complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block, or PR interval > 250 msec.
    3. Any factors may increase the risk of QTc prolongation or arrhythmic event.
    4. Left ventricular ejection fraction (LVEF) < 50%.
  3. Patient weight still in losing period.
  4. History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as esophageal varices with high risk of bleeding, local active ulcerative lesions, fecal occult blood test>= (+ +) within the past 6 months, shall not enter the trial. If fecal occult blood test (+), the patient is requested for gastroscopy.
  5. Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial.
  6. Patients with coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulant therapy.
  7. Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, for example, HBV, HCV, or HIV.
  8. Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-1.
  9. Patients with mental illness, or with psychiatric history of drug abuse.

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): NCT03278015


Contacts
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Contact: Dabin Xu, M.D. 8613522065659 xdabin@126.com

Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100853
Sponsors and Collaborators
Chinese PLA General Hospital
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Responsible Party: Dabin Xu, Associate Chief Doctor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03278015    
Other Study ID Numbers: XDB-001
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

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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 Dabin Xu, Chinese PLA General Hospital:
S-1
nab-paclitaxel
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
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
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs