Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)

NCT04787354 | Recruiting Phase 3

• 1 other identifier: KCSG ST21-05
• Study Type: interventional
• Target: 976
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the efficacy and safety of reduced adjuvant XELOX treatment (4 cycles of XELOX followed by 4 cycles of capecitabine alone) to standard adjuvant XELOX treatment (8 cycles of XELOX).

Conditions

Gastric Cancer

Keywords

Stomach Neoplasms; Chemotherapy, Adjuvant; Oxaliplatin; Capecitabine

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  The disease-free survival (DFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause

  3-year

Secondary Outcomes (2)

• overall survival

  5-year

• Toxicity profiles

  3-year

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Standard adjuvant XELOX 8 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, total 8 cycles

Drug: Oxaliplatin; Drug: Capecitabine

Study arm

EXPERIMENTAL

Adjuvant XELOX 4 cycles followed by capecitabine monotherapy 4 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, 4 cycles followed by Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, 4 cycles

Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Oxaliplatin DRUG

Oxaliplatin: 130 mg/m2/day

Control arm; Study arm

Capecitabine DRUG

Capecitabine: 2,000 mg/m2/day

Control arm; Study arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection)
• Pathologically confirmed stage II, III patients (AJCC 8th edition)
• Age 19 years and older
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
• Adequate marrow function (ANC \> 1,500/uL, Platelet \>100,000/uL, Hb \> 8.0 g/dL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study)
• Adequate renal function, with serum creatinine \< 1.5 x upper limit of normal (ULN).
• Adequate hepatic function with serum total bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN
• Written, informed consent to the study

You may not qualify if:

• Female patients who are pregnant or breast-feeding
• Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile)
• Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug
• Evidence of metastasis (including cytologically confirmed malignant ascites)
• Prior systemic chemotherapy or radiation therapy for stomach cancer
• Patients who have not recovered from serious complications of gastrectomy
• History of other malignancies within the last 3 years (excluding adequately treated basal cell carcinoma of the skin, in situ cancer of the cervix, non-metastatic thyroid cancer)
• A history of clinically significant uncontrolled seizures, central nervous system disorders, or mental disorders, which make it impossible to understand the informed consent or interfere with compliance with oral drug intake
• Clinically significant (i.e., active) heart disease: e.g. unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure with NYHA grade II or higher, severe cardiac arrhythmias or acute coronary syndrome in the past 6 months (including myocardial infarction)
• Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug
• Serious uncontrolled infection or other serious uncontrolled disease
• History of allograft requiring immunosuppression therapy
• Received any investigational drug or procedure within 4 weeks prior to randomization
• Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU/mL, and are allowed to use prophylactic antiviral agents by investigator's choice)
• Active HIV infection

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Medical Center

Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Bum Jun Kim, Dr

CONTACT

82-31-380-3704; getwisdom1025@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 8, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 21, 2022

Record last verified: 2022-02

Locations

KR (1)