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2020-01-05
2022-06-30
2023-06-30
231
NCT03959150
Ruijin Hospital
Ruijin Hospital
INTERVENTIONAL
Metronomic Chemotherapy With Capecitabine for Pancreatic Cancer
The latest guidelines recommend Gemcitabine plus Capecitabine as the first choice of adjuvant chemotherapy for pancreatic cancer patients in good physical condition. In order to prolong the survival of patients and improve the cure rate, metronomic chemotherapy with capecitabine is a safe, effective and economical treatment mode after adjuvant chemotherapy. This study is trying to determine that compared with observation group, if capecitabine metronomic medication is a better choice after adjuvant chemotherapy.
Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used in adjuvant therapy for pancreatic cancer. It is usually taken twice a day (in the morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next dosage cycle. In this study, capecitabine will be prescribed as dosage of 500mg/m2, and maintain for a whole year after the standard treatment in stage II/III pancreatic cancer patients. 1 year disease-free survival is set as the primary outcome, OS, RFS, AEs and exploratory biomarkers including effects of metronome chemotherapy on immune cells, such as NK cells, T cells, TAMs, B cells, etc are also observed as the secondary outcomes. Statistical analysis are made to see compared with observation group, whether this metronomic therapy of capecitabine ( 500mg/m2) will bring benefit to pancreatic cancer patients.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-05-18 | N/A | 2021-04-29 |
2019-05-21 | N/A | 2021-04-30 |
2019-05-22 | N/A | 2021-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Capecitabine metronomic chemotherapy Capecitabine 500mg/m2 po qd | DRUG: Capecitabine
|
| NO_INTERVENTION: Observation Observation |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| One year disease-free survival | was defined as the rate of disease recurrence, metastasis or death due to disease progression within 1 year after the surgery | 1 year |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | was defined as the time from the date of surgery until the date of any death occurred | 5 year |
| Recurrence-free Survival (RFS) | was defined as the time from the date of surgery until the date of local recurrence of the tumor | 1 year |
| AEs | Hand and foot syndrome and other treatment related AE | 5 year |
| Exploratory biomarkers | including effects of metronome chemotherapy on immune cells, such as NK cells, T cells, TAMs, B cells, etc | 1 yaer |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Jun Zhang, MD & Ph. D Phone Number: +86-13818332497 Email: junzhang10977@sjtu.edu.cn |
Study Contact Backup Name: Jinling Jiang, MD & MS Phone Number: +86-21-13816423993 Email: jiangjinling2000@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
