Metronomic Chemotherapy With Capecitabine for Pancreatic Cancer

April 29, 2021 updated by: Jun Zhang, Ruijin Hospital

A Multi-center, II Phase，Randomized Controlled Clinical Study of Capecitabine Metronomic Chemotherapy After Gemcitabine Plus Capecitabine Standard Adjuvant Therapy for Stage II/III 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

231

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Department of Oncology, Ruijin Hospital
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed pancreatic invasive ductal adenocarcinoma.
  2. The patient underwent surgery for pancreatic tumor resection, and no gross residual lesions were found postoperatively (R2).
  3. Stage II/III pancreatic cancer was determined according to AJCC/UICC TNM stage eighth.
  4. At least 6 cycles of gemcitabine plus capecitabine chemotherapy have been completed.
  5. Age 18-70 years old, gender not limited.
  6. ECOG performance score is 0 or 1.
  7. Without dysphagia, able to tolerate oral administration.
  8. No relevant clinical or imaging evidence of recurrence or metastasis showing within the 28 days before random.
  9. Chemotherapy with capecitabine combined with gemcitabine regimen was given within 12 weeks after surgery, and last chemotherapy to random time ≤ 6 weeks.
  10. Adequate bone marrow, liver, and kidney function in measurements taken within 7 days before registration ：

  11. Hemoglobin ≥ 90 g/L, Platelet count ≥ 100×109/L, Absolute granulocyte count ≥ 1.5×109/L.

    i. Note: patients should not receive blood transfusion or growth factor support within 14 days before collection of blood samples.

  12. Serum creatinine≤ 1.5 ULN, and calculated creatinine clearance of ≥ 60 mL/min/1.73m2.
  13. AST and ALT ≤ 2.5 X ULN, serum total bilirubin ≤ 1.5 X ULN (Patients with Gilbert syndrome with total bilirubin≤ 3 X ULN can be enrolled).
  14. INR or PT ≤ 1.5×ULN，unless the patient is receiving anticoagulant therapy and the PT value is within the expected therapeutic range of the anticoagulant.
  15. Electrocardiogram and cardiac function were not contraindicated in chemotherapy.
  16. Women should have a negative pregnancy test, and all the patients have no planning within 3 years and should take contraceptive measures during treatment.
  17. Informed consent form signed.

Exclusion Criteria:

  1. Other pathological types of pancreatic malignancies (e.g. neuroendocrine carcinoma, large cell carcinoma, signet ring cell carcinoma, etc.).
  2. With distant metastasis or malignant pleural effusion.
  3. Pregnant and breast-feeding women.
  4. Unable to oral medication.
  5. Previous or concurrent malignancies, excluding curatively treated in situ carcinoma of the cervix or non-melanoma skin cancer, unless at least 5 years have elapsed since last treatment and the patient is considered cured.
  6. A history of transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary embolism or deep venous thrombosis) within 180 days before randomization.
  7. Any of the following uncontrolled or severe cardiovascular disease history:
  8. Myocardial infarction occurred 180 days before randomization.
  9. Uncontrolled angina occurred within 180 days before randomization.
  10. Heart failure of class III or IV (according to New York Heart Association functional classification).
  11. Uncontrolled hypertension after appropriate treatment (e.g. Systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg for 24h or longer).
  12. Arrhythmias that require treatment, including pacemakers.
  13. Serious drug allergy.
  14. Uncontrolled diabetes or systemic infection.
  15. Known dihydro pyrimidine dehydrogenase (DPD) deficiency.
  16. Any other reasons the investigator considers the patient should not participate in the study.
  17. Without personal freedom and independent civil capacity.
  18. Already enrolled into other clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observation
Experimental: Capecitabine metronomic chemotherapy
Capecitabine 500mg/m2 po qd
Drug: Capecitabine
Oral fluorouracil
Other Names:
  • Xeloda

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One year disease-free survival
Time Frame: 1 year
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

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 5 year
was defined as the time from the date of surgery until the date of any death occurred
5 year
Recurrence-free Survival (RFS)
Time Frame: 1 year
was defined as the time from the date of surgery until the date of local recurrence of the tumor
1 year
AEs
Time Frame: 5 year
Hand and foot syndrome and other treatment related AE
5 year
Exploratory biomarkers
Time Frame: 1 yaer
including effects of metronome chemotherapy on immune cells, such as NK cells, T cells, TAMs, B cells, etc
1 yaer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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 Major Dates

Study Start (Actual)

January 5, 2020

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

May 18, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 29, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metro-PC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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