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

Primary Purpose

Pancreatic Cancer, Neoadjuvant Chemotherapy

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S1,

Paclitaxel-albumin

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring S-1, Paclitaxel-albumin, Unresectable Pancreatic Cancer, Neoadjuvant chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Confirmed invasive ductal adenocarcinoma of pancreas by histology
Evaluated as CT4N0M0 pancreatic cancer patients by Image testing
Adults age from 18-80 years old
No history of pancreatic resection or pancreatic cancer
ECOG score 0-1; can be orally administered
No distant metastasis or malignant ascites
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
Sign the Informed consent -

Exclusion Criteria:

Woman in pregnant or lactation period
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.
Men and women who had sexual life (Fertility possibility) were reluctant to have contraception during the study period.
Patients with the history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ.
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
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.
Patients with upper gastrointestinal obstruction or Abnormal physiological function or Malabsorption syndrome, which may affect the absorption of S-1.
Organ transplant patients who need immunosuppressive therapy
Patients with Serious uncontrolled repeated infection or other serious uncontrolled Concomitant disease.
Patient that is lack of dihydropyrimidine dehydrogenase (DPD)
Allergic to any of the drug ingredients in this study
participate in other clinical trials within 4 weeks before randomization -

Sites / Locations

Zhejiang procincial people's hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 combined with Paclitaxel-albumin

Arm Description

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.

Outcomes

Primary Outcome Measures

R0 resection rate

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

The objective remission rate (ORR)

Evaluate the objective remission rate (ORR) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

The disease free survival (DFS)

Evaluate the disease free survival (DFS) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

The 2 year and 5 year survival rate

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

The quality of life

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.

Full Information

NCT ID

NCT03585062

First Posted

January 8, 2018

Last Updated

January 6, 2021

Sponsor

Zhejiang Provincial People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03585062

Brief Title

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

Official Title

Clinical Trial of Neoadjuvant Chemotherapy With S1 Plus Paclitaxel-albumin in Patients With Unresectable Locally Advanced Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Terminated

Why Stopped

The paclitaxel-albumin halt production.

Study Start Date

November 20, 2017 (Actual)

Primary Completion Date

July 1, 2019 (Actual)

Study Completion Date

July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhejiang Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

BACKGROUND: 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. Studies have shown that neoadjuvant therapy improves the quality of surgery in patients with pancreatic cancer，and prolong their life. 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 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. Paclitaxel-albumin: 125 mg/m2, intravenous infusion for 30 minutes, Day1 and Day 8. Repeat every three weeks. for 6 cycles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Neoadjuvant Chemotherapy

Keywords

S-1, Paclitaxel-albumin, Unresectable Pancreatic Cancer, Neoadjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

S-1 combined with Paclitaxel-albumin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

S1,

Other Intervention Name(s)

Gimeracil and Oteracil Porassium Capsules

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Paclitaxel-albumin

Intervention Description

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

Primary Outcome Measure Information:

Title

R0 resection rate

Description

Evaluate the R0 resection rate of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

Time Frame

one week After the operation

Secondary Outcome Measure Information:

Title

The objective remission rate (ORR)

Description

Evaluate the objective remission rate (ORR) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

Time Frame

at the end of cycle 6 of the neoadjuvant chemotherapy((each cycle is 21 days)

Title

The disease free survival (DFS)

Description

Evaluate the disease free survival (DFS) of S-1 combined with Paclitaxel-albumin as neoadjuvant chemotherapy in patients with unresectable locally advanced pancreatic cancer

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.

Title

The 2 year and 5 year survival rate

Description

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

Time Frame

2 years and 5 years after treatment

Title

The quality of life

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Confirmed invasive ductal adenocarcinoma of pancreas by histology Evaluated as CT4N0M0 pancreatic cancer patients by Image testing Adults age from 18-80 years old No history of pancreatic resection or pancreatic cancer ECOG score 0-1; can be orally administered No distant metastasis or malignant ascites 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 Sign the Informed consent - Exclusion Criteria: Woman in pregnant or lactation period 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. Men and women who had sexual life (Fertility possibility) were reluctant to have contraception during the study period. Patients with the history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ. 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 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. Patients with upper gastrointestinal obstruction or Abnormal physiological function or Malabsorption syndrome, which may affect the absorption of S-1. Organ transplant patients who need immunosuppressive therapy Patients with Serious uncontrolled repeated infection or other serious uncontrolled Concomitant disease. Patient that is lack of dihydropyrimidine dehydrogenase (DPD) Allergic to any of the drug ingredients in this study participate in other clinical trials within 4 weeks before randomization -

Facility Information:

Facility Name

Zhejiang procincial people's hospital

City

Hanzhou

State/Province

Zhejiang

ZIP/Postal Code

310014

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23335087

Citation

Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.

Results Reference

background

PubMed Identifier

21296855

Citation

Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.

Results Reference

background

PubMed Identifier

22991309

Citation

Witkowski ER, Smith JK, Tseng JF. Outcomes following resection of pancreatic cancer. J Surg Oncol. 2013 Jan;107(1):97-103. doi: 10.1002/jso.23267. Epub 2012 Sep 18.

Results Reference

background

PubMed Identifier

15028824

Citation

Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Buchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. doi: 10.1056/NEJMoa032295. Erratum In: N Engl J Med. 2004 Aug 12;351(7):726.

Results Reference

background

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

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