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RecruitingNCT04787354Updated Feb 21, 2022

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

A Phase 3 interventional study of Oxaliplatin and Capecitabine in Gastric Cancer, sponsored by Hallym University Medical Center. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-02-21.

Sponsored by Hallym University Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Nov 2021; still recruiting 4 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
976
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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 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).

02

Conditions studied

  • Gastric Cancer

Browse trials for

Keywords

  • Stomach Neoplasms
  • Chemotherapy, Adjuvant
  • Oxaliplatin
  • Capecitabine
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 976 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Hallym University Medical Center is the lead sponsor of 53 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Patients with peripheral sensory neuropathy with functional impairment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
976 participants (estimated)

Study arms

  • Active comparator
    Control arm

    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

  • Experimental
    Study arm

    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

06

What researchers measure

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

    Time frame: 3-year

Secondary outcomes

  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

    Time frame: 5-year

  2. Toxicity profiles

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

    Time frame: 3-year

07

Study locations

1 of 1 sites recruiting
  • Hallym University Medical Center
    Gyeonggi-do, South Korea
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2021 (actual). Primary completion is estimated for Dec 2024, 37 months after the start.

Of 69 non-industry phase 3 interventional studies under Stomach Neoplasms, half reached primary completion within 98 months of starting (the median), counting those still running; a quarter within 52 and three quarters within 144. This study's planned 37 months is below that.

Counting every sponsor, half of 109 studies reached it within 52 months; a quarter within 39 and three quarters within 102.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2021
First posted
Mar 8, 2021
StartActual
Nov 1, 2021
Primary completionEst.
Dec 31, 2024
CompletionEst.
Dec 31, 2027
Last update
Feb 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04787354
Lead sponsor
Hallym University Medical Center
Responsible party
Zang, Dae Young (Principal Investigator, Hallym University Medical Center) — Principal investigator
First posted
Mar 8, 2021
Start date
Nov 1, 2021
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Feb 21, 2022

Study contacts

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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Oxaliplatin · Capecitabine

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