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Trial record 40 of 2838 for:    Pancreatic Cancer

Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin on Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03585062
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Yi-Ping Mou, Zhejiang Provincial People’s Hospital

Brief Summary:
The study is to evaluate the R0 resection rate of patients with unresectable locally advanced pancreatic cancer ,after treated with S-1 plus Paclitaxel-albumin as neoadjuvant chemotherapy protocols

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Neoadjuvant Chemotherapy Drug: S1, Drug: Paclitaxel-albumin Phase 2

Detailed Description:

BACKGROUND:

  1. The incidence of pancreatic cancer in China has been increasing rapidly in recent years,but most of the pancreatic cancer patients are unresectable, whose median survival time were only 6~9 months.
  2. Studies have shown that neoadjuvant therapy improves the quality of surgery in patients with pancreatic cancer,and prolong their life.
  3. S-1 is a new generation of oral fluorouracil derivatives ,S-1 single drug as an adjuvant therapy for resectable pancreatic cancer is better than gemcitabine, and has less side effects than gemcitabine. Protein bound paclitaxel is a novel paclitaxel combined of paclitaxel and albumin by nanotechnology , which can extend free survival in patients with advanced pancreatic cancer with less side effects than gemcitabine. So S-1 combined with Paclitaxel-albumin is expected to play an important role in neoadjuvant chemotherapy in Pancreatic cancer, and may improve the rate of R0 resection in patients with unresectable locally advanced pancreatic.

STUDY DESIGN:

S-1 combined with Paclitaxel-albumin

  1. S-1:40~60mg bid, day 1~14 (S-1: BSA (Body surface area)<1.25m2, 40mg bid , 1.25m2 ≤ BSA ≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid),2 weeks and rest for 1 weeks.
  2. Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.

Repeat every three weeks. for 6 cycles.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin in Patients With Unresectable Locally Advanced Pancreatic Cancer
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: S-1 combined with Paclitaxel-albumin
S-1 combined with Paclitaxel-albumin S-1:40~60mg bid, day 1~14 (S-1: BSA <1.25m2, 40mg bid , 1.25m2 ≤ BSA ≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid, for 2 weeks, rest a week) Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8.
Drug: S1,
S-1 is a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1, and is a new oral fluoropyrimidine anticancer agent shown to be effective for pancreatic cancer. cancer
Other Name: Gimeracil and Oteracil Porassium Capsules

Drug: Paclitaxel-albumin
Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: one week After the operation ]
    Evaluate the R0 resection rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer


Secondary Outcome Measures :
  1. The objective remission rate (ORR) [ Time Frame: at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days) ]
    Evaluate the objective remission rate (ORR) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

  2. The disease free survival (DFS) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 60 months. Progressing should be confirmed by imaging examination or histology / cytology examination. ]
    Evaluate the disease free survival (DFS) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

  3. The 2 year and 5 year survival rate [ Time Frame: 2 years and 5 years after treatment ]
    Evaluate the 2 year and 5 year survival rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

  4. The quality of life [ Time Frame: Questionnaire at baseline, and then 1-2 days before each cycle of treatment(each cycle is 21 days, for a total of 6 cycles.). During follow-up period after treatment, questionnaire every 6 months, up to 2 years. ]
    Assess the quality of life in pancreatic cancer according to EORTC QLQ-PAN26(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Pancreas 26).For each assessment item, there are four options, scores are as 1,2,3,4. Each score corresponds to a physical condition. Then have the total score for each patient. The total score range from 26-104, the higher the score, the poorer the quality of life is.



Information from the National Library of Medicine

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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. Confirmed invasive ductal adenocarcinoma of pancreas by histology
  2. Evaluated as CT4N0M0 pancreatic cancer patients by Image testing
  3. Adults age from 18-80 years old
  4. No history of pancreatic resection or pancreatic cancer
  5. ECOG score 0-1; can be orally administered
  6. No distant metastasis or malignant ascites
  7. Relatively good liver、 kidney、heart、hematology function. Baseline blood routine and biochemical indexes of the subjects meet the following criteria: hemoglobin ≥90g/L;absolute neutrophil count(ANC)≥3.5×109/L;Platelet≥100×109/L;prothrombin time ≤1.8;partial thromboplastin time ≤1.8; ALT≤102U/L、AST≤95U/L; ALP≤2.5 times the upper limits of normal; Serum total bilirubin≤2.5 g/dL(total bilirubin ≤1.5 times the upper limit of normal (ULN);Serum creatinine≤2.0 mg/dL; creatinine clearance rate >50 ml/min
  8. Sign the Informed consent -

Exclusion Criteria:

  1. Woman in pregnant or lactation period
  2. Woman of childbearing age who was positive at baseline pregnancy test or did not have pregnancy tests.Menopausal women must have menopause for at least 12 months before they think they are free of pregnancy.
  3. Men and women who had sexual life (Fertility possibility) were reluctant to have contraception during the study period.
  4. Patients with the history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
  5. Patients of uncontrolled epilepsy, central nervous system diseases or history of mental disorders, should be judged by the researchers whether their clinical severity hinder the signature of the informed consent or influenced patients'compliance with oral medications
  6. Clinically serious (i.e. activity) heart disease, such as symptomatic coronary heart disease , New York Heart Association (NYHA) class II or more serious congestive heart failure or serious arrhythmia which need drug intervention, or have a history of MI within the last 12 months.
  7. Patients with upper gastrointestinal obstruction or Abnormal physiological function or Malabsorption syndrome, which may affect the absorption of S-1.
  8. Organ transplant patients who need immunosuppressive therapy
  9. Patients with Serious uncontrolled repeated infection or other serious uncontrolled Concomitant disease.
  10. Patient that is lack of dihydropyrimidine dehydrogenase (DPD)
  11. Allergic to any of the drug ingredients in this study
  12. participate in other clinical trials within 4 weeks before randomization -

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): NCT03585062


Contacts
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Contact: Liu Yang, Doctor 13666601475 yangliuqq2003@163.com

Locations
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China, Zhejiang
Zhejiang procincial people's hospital Recruiting
Hanzhou, Zhejiang, China, 310014
Contact: Liu Yang    13666601475    yangliuqq2003@163.com   
Sponsors and Collaborators
Zhejiang Provincial People’s Hospital

Publications:
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Responsible Party: Yi-Ping Mou, Vice Present of Zhejiang Provincial People's Hospital, Zhejiang Provincial People’s Hospital
ClinicalTrials.gov Identifier: NCT03585062     History of Changes
Other Study ID Numbers: 2017KY007
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Yi-Ping Mou, Zhejiang Provincial People’s Hospital:
S-1
Paclitaxel-albumin
Unresectable Pancreatic Cancer
Neoadjuvant chemotherapy

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
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action