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New treatment option for Gastric Cancer
Official title Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)
ClinicalTrials.gov ID: NCT04787354
What this study is testing
What is Oxaliplatin?
Oxaliplatin is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2...
- 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...
You likely can't join 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
See the full eligibility 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
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gyeonggi-do, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gyeonggi-do, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.