A Clinical Trial of Two Adjuvant Chemotherapy Regimens for Postoperative Gastric Cancer

NCT04351867 | Unknown Phase 3

• 1 other identifier: GC202001
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

This study was a prospective, randomized, controlled phase III clinical study to evaluate the efficacy and safety of docetaxel plus oxaliplatin and capecitabine versus oxaliplatin plus capecitabine in the treatment of gastric or gastroesophageal junction adenocarcinoma with postoperative pathological stage IIIB and IIIC.

Conditions

Stomach Neoplasms

Outcome Measures

Primary Outcomes (1)

• disease free survival

  From the date of randomization until the date of the first recorded disease recurrence, metastasis or death from any cause, whichever came first.

  up to three years.

Secondary Outcomes (3)

• overall survival

  up to three years.

• Adverse reaction

  up to three years.

• Assessment of life quality

  up to three years.

Study Arms (2)

experimental group

EXPERIMENTAL

docetaxel plus oxaliplatin and capecitabine

Drug: docetaxel plus oxaliplatin and capecitabine

control group

ACTIVE COMPARATOR

oxaliplatin plus capecitabine

Drug: oxaliplatin plus capecitabine

Interventions

docetaxel plus oxaliplatin and capecitabine DRUG

docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

Also known as: Three medicine combined

experimental group

oxaliplatin plus capecitabine DRUG

oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d

Also known as: Two medicine combined

control group

Eligibility Criteria

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

You may qualify if:

• Have signed the informed consent and can comply with the visit and related procedures stipulated in the program
• Age ≥18 years old and ≤75 years old
• D2 radical resection was performed within 21-60 days before the beginning of the first cycle of chemotherapy in this clinical study
• Preoperative neoadjuvant chemotherapy was not performed and Gastric and gastroesophageal junction adenocarcinoma (including signed-ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma) at stage IIIB and IIIC were confirmed by postoperative pathological staging. Note: the presence of distant metastases should be confirmed by a CT or MRI scan.ECT should be performed if bone metastases are suspected.If peritoneal metastases are suspected, laparoscopy should be performed
• Postoperative ECOG score was 0 or 1
• Leukocyte ≥ 4×109/L, platelet ≥ 100×109/L without blood transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without granulocyte stimulating factor treatment, and hemoglobin ≥ 90 g/L
• Bilirubin ≤ 1.5 times of the upper limit of normal value, glutamic oxalacetic transaminase and glutamic-pyruvic transaminase ≤ 2.5 times of the upper limit of normal value
• Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45 ml/min
• Serum albumin ≥ 25 g/L (2.5g /dL)
• INR or PT ≤ 1.5 times ULN
• Hepatitis b surface antigen positive patients need to be tested for hepatitis b DNA virus quantitative detection, only \< the upper limit of the normal detection value can be included in the group, and should long-term use of anti-hepatitis b drugs
• Tumor specimens can be provided for consultation (if the patient's surgical specimen comes from another hospital), protein and gene testing

You may not qualify if:

• Postoperative wound healing is poor and chemotherapy is not appropriate to start
• Recurrent patients or suspected peritoneal metastases after radical surgery
• Known DPD enzyme deficiency
• Allergy to, or history of severe allergy to, or contraindication to any of the experimental drugs or its excipients
• Patients who are expected to require major surgery during the study period
• Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or CT-confirmed active pneumonia
• Tested positive for HIV
• Active hepatitis b or c
• Only liquid diet was allowed after the operation, with BMI \<18kg/m2
• Uncontrolled pain
• A history of antitumor drug therapy other than radical surgery
• Severe infection in the active stage or with poor clinical control
• Use of hormones is contraindicated
• Severe cardiovascular disease, myocardial infection or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
• Uncontrollable increase in blood pressure or blood sugar

Sponsors & Collaborators

• LiNing: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ning Li, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Suxia Luo, PhD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li, PhD

CONTACT

0086-13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: April 17, 2020
• Study Start: September 1, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 1 year after completion of the main part
• Access Criteria: public management platform ResMan (www.medresman.org) was adopted to provide open access to the public

Locations

CN (1)