Metronomic Chemotherapy With Capecitabine for Pancreatic Cancer

NCT03959150 | Unknown Phase 2 DMC

• 1 other identifier: Metro-PC
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Survival (OS)

  5 year

• Recurrence-free Survival (RFS)

  1 year

• AEs

  5 year

• Exploratory biomarkers

  1 yaer

Study Arms (2)

Capecitabine metronomic chemotherapy

EXPERIMENTAL

Capecitabine 500mg/m2 po qd

Drug: Capecitabine

Observation

NO INTERVENTION

Observation

Interventions

Capecitabine DRUG

Oral fluorouracil

Also known as: Xeloda

Capecitabine metronomic chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed pancreatic invasive ductal adenocarcinoma.
• The patient underwent surgery for pancreatic tumor resection, and no gross residual lesions were found postoperatively (R2).
• Stage II/III pancreatic cancer was determined according to AJCC/UICC TNM stage eighth.
• At least 6 cycles of gemcitabine plus capecitabine chemotherapy have been completed.
• Age 18-70 years old, gender not limited.
• ECOG performance score is 0 or 1.
• Without dysphagia, able to tolerate oral administration.
• No relevant clinical or imaging evidence of recurrence or metastasis showing within the 28 days before random.
• Chemotherapy with capecitabine combined with gemcitabine regimen was given within 12 weeks after surgery, and last chemotherapy to random time ≤ 6 weeks.
• Adequate bone marrow, liver, and kidney function in measurements taken within 7 days before registration ：
• 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.
• Serum creatinine≤ 1.5 ULN, and calculated creatinine clearance of ≥ 60 mL/min/1.73m2.
• 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).
• 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.

You may not qualify if:

• Other pathological types of pancreatic malignancies (e.g. neuroendocrine carcinoma, large cell carcinoma, signet ring cell carcinoma, etc.).
• With distant metastasis or malignant pleural effusion.
• Pregnant and breast-feeding women.
• Unable to oral medication.
• 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.
• A history of transient ischemic attack, cerebrovascular accident, thrombosis, or thromboembolism (pulmonary embolism or deep venous thrombosis) within 180 days before randomization.
• Any of the following uncontrolled or severe cardiovascular disease history:
• Myocardial infarction occurred 180 days before randomization.
• Uncontrolled angina occurred within 180 days before randomization.
• Heart failure of class III or IV (according to New York Heart Association functional classification).
• Uncontrolled hypertension after appropriate treatment (e.g. Systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg for 24h or longer).
• Arrhythmias that require treatment, including pacemakers.
• Serious drug allergy.
• Uncontrolled diabetes or systemic infection.
• Known dihydro pyrimidine dehydrogenase (DPD) deficiency.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Oncology, Ruijin Hospital

Shanghai, 200025, China

RECRUITING

Related Publications (14)

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jun Zhang, MD & Ph. D

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Zhang, MD & Ph. D

CONTACT

+86-13818332497; junzhang10977@sjtu.edu.cn

Jinling Jiang, MD & MS

CONTACT

+86-21-13816423993; jiangjinling2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Oncology

Study Record Dates

• First Submitted: May 18, 2019
• First Posted: May 22, 2019
• Study Start: January 5, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: April 30, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)