Gastric Cancer
Conditions
Keywords
Adjuvant chemotherapy, Gastric Cancer, Non-inferiority, Oxaliplatin, Capecitabine
Brief summary
Our study aims to compare 4 months versus 6 months of adjuvant capecitabine plus oxaliplatin after D2 gastrectomy in patients with gastric cancer. Hypothesis: We hypothesize that a 4-month regimen of capecitabine plus oxaliplatin is noninferior to a 6-month regimen with respect to DFS and is associated with lower treatment-related toxicity.
Detailed description
Surgical resection is the cornerstone of treatment for patients with localized gastric cancer. In the CLASSIC trial, capecitabine plus oxaliplatin for 6 months following D2 gastrectomy has been established as a standard postoperative adjuvant treatment for patients with operable stage II or III gastric cancer. However, due to adverse events, chemotherapy was discontinued in 50 patients (10%), primarily due to nausea, neutropenia, decreased appetite, peripheral neuropathy, diarrhea, and vomiting. At the 2017 ASCO Annual Meeting, Grothey et al. reported the results of the IDEA trial. For patients with lymph node-positive colon cancer (stage III), some patients may benefit from a shorter duration of postoperative chemotherapy. An analysis of six clinical trials involving over 12,800 patients showed that 3 months of chemotherapy was nearly as effective as 6 months for patients with a lower recurrence risk, while also causing fewer side effects, particularly nerve damage. Based on the findings from the IDEA trial, we hypothesize that a 4-month regimen of capecitabine plus oxaliplatin may also benefit patients following D2 gastrectomy while reducing adverse events compared with the standard 6-month regimen.
Interventions
DRUGOxaliplatin
Oxaliplatin 130 mg/m2
DRUGCapecitabine
Capecitabine 1000 mg/m2
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 80 years. 2. Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction, staged as II, IIIA, or IIIB according to the American Joint Committee on Cancer classification system, eighth edition. 3. Underwent R0 gastrectomy with D2 lymphadenectomy. 4. No other concurrent malignancies. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. No contraindications to chemotherapy.
Exclusion criteria
1. Receipt of preoperative treatment, including radiation therapy, chemotherapy, or immunotherapy. 2. Patients with stage I, IIIC, or IV gastric cancer. 3. Severe cardiac, pulmonary, neurologic, hepatic, or other major organ dysfunction. 4. Known or suspected drug allergies. 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DFS | 3 years | Disease-free survival, defined as the time from randomization to the first occurrence of disease recurrence or death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 6 months | Adverse Events of Chemotherapy |
| OS | 3 years | Overall survival, defined as the time from randomization to death from any cause. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDazhi Xu, PHD, MD
Fudan University
Outcome results
None listed