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Gastric CancerPhase 3NCT04787354

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

A Phase 3 study testing Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Hallym University Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Oxaliplatin and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
976 participants
Where
1 siteSouth Korea
Study dates
1 Nov 2021to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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
  • Patients with peripheral sensory neuropathy with functional impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bum Jun Kim, Dr contact

82-31-380-3704

getwisdom1025@gmail.com

South Korea1 site, 1 recruiting

  • Hallym University Medical Center

    Gyeonggi-do

    Bum Jun Kim, 82-31-380-3704, getwisdom1025@gmail.com

    Recruiting

Other trials in South Korea

About this study

Official title: A Randomized Phase 3 Clinical Trial Investigating Optimal Duration of Oxaliplatin Administration in Postoperative XELOX (Oxaliplatin + Capecitabine) Adjuvant Chemotherapy for the Patients With Stage II/III Gastric Cancer

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).

Read the detailed description

XELOX (oxaliplatin + capecitabine) combination chemotherapy is considered a standard adjuvant treatment for curatively resected gastric cancer patients after it proved its effecacy in the CLASSIC trial. Adjuvant XELOX chemotherapy is a long-term treatment with a total treatment period of 6 months and it is known that about 33% of patients cannot complete treatment schedule due to side effects. In particular, peripheral neuropathy, which is caused by the cumulative administration of oxaliplatin, is a major cause of lowering the patient's quality of life and treatment compliance, and it is known that the incidence rate increases when standard XELOX treatment is continued for more than 6 cycles. In colorectal cancer, clinical studies have been actively conducted to shorten the duration of standard adjuvant chemotherapy to reduce the peripheral sensory neuropathy caused by oxaliplatin, but there are no relevant studies in gastric cancer.

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
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04787354
Study groupRoleWhat they receive
Control armActive comparatorStandard 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
Receives: Drug: Oxaliplatin; Drug: Capecitabine
Study armExperimentalAdjuvant 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
Receives: Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3-year

Secondary outcomes (2)

  1. overall survival

    The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method

    Measured: 5-year

  2. Toxicity profiles

    Adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 5.0

    Measured: 3-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2021
  2. Study start1 Nov 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
976 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04787354
Sponsor's protocol ID
KCSG ST21-05
Status last verified
Feb 2022
First submitted
2 Mar 2021
Last updated
21 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Hallym University Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bum Jun Kim, Dr (82-31-380-3704, getwisdom1025@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival (time frame: 3-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04787354.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.

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