An observational study in Gastric Cancer, sponsored by The First Affiliated Hospital of Zhengzhou University. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by The First Affiliated Hospital of Zhengzhou University · Observational
The goal of this retrospective study is to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.
Due to a heavy metastatic node burden, pathological stage N3 (pN3) gastric cancer (GC) patients have extremely poor prognoses. Except for surgical resection, postoperative adjuvant chemotherapy is the major treatment strategy to improve survival for these patients. Capecitabine plus oxaliplatin (CapOx) and S-1 plus oxaliplatin (SOX) were considered the effective treatment for stage II and III GC after D2 gastrectomy in the CLASSIC and RESOLVE trials. But N3b (positive lymph nodes ≥16) and T1-3N3 patients were omitted in these two trials, respectively. Moreover, only 66.5% of patients finished 6 months of chemotherapy in the CLASSIC trial, and in the RESOLVE trial, 17-19% of patients required dose reductions and about 19% of patients discontinued chemotherapy due to drug-related toxicity for 6 months of chemotherapy. Particularly, cumulative administration of oxaliplatin led to peripheral sensory neurotoxicity, which caused poor quality of life and treatment compliance. Recently, a prospective analysis of six randomized, phase 3 trials with 12834 participants (IDEA trail) for stage III colon cancer, demonstrated that 3 months of CapOx was as effective as 6 months with relatively lower recurrence risk, no significantly different overall survival, and fewer adverse effects. However, there were no relevant studies to explore the optimal duration of chemotherapy for pN3 GC patients.
This study aims to compare the efficacy and safety of 3-4 months to 5-6 months of CapOx/SOX adjuvant chemotherapy in pathological N3 gastric cancer patients.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 260 is close to the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →The First Affiliated Hospital of Zhengzhou University is the lead sponsor of 123 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Gastric cancer patients who underwent D2 or D2+ procedure and pathologically confirmed stage N3 (AJCC 8th edition)
Exclusion Criteria:
Adjuvant CapOx/SOX 3-4 months after curative surgery: CapOx: Oxaliplatin: 130 mg/m²/day (day 1) , Capecitabine: 1,000 mg/m², bid (day 1-14), q3W, total 3-4 months (4-6 cycles); SOX: Oxaliplatin: 130 mg/m2/day(day 1) , S-1: 40-60 mg, bid (day 1-14), q3W, total 3-4 months (4-6 cycles)
Drug: Oxaliplatin and capecitabine/ S-1 and capecitabine
Adjuvant CapOx/SOX 5-6 months after curative surgery: CapOx: Oxaliplatin: 130 mg/m²/day (day 1) , Capecitabine: 1,000 mg/m², bid (day 1-14), q3W, total 5-6 months (7-8 cycles); SOX: Oxaliplatin: 130 mg/m2/day(day 1) , S-1: 40-60 mg, bid (day 1-14), q3W, total 5-6 months (7-8 cycles)
Drug: Oxaliplatin and capecitabine/ S-1 and capecitabine
Drug: capecitabine: 1000 mg/m² bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1; S-1: BSA\<1.25m², 40mg bid, 1.25m²≤BSA≤1.5m², 50mg bid, BSA\>1.5m², 60mg bid, po, d1-14, oxaliplatin: 130mg/m², iv drip for 2h, d1
Also known as: Xeloda
Overall Survival
The overall survival (OS) will be calculated from the day of surgery to participant's death with any cause
Time frame: 3 years
Disease Free Survival
The Disease Free Survival (DFS) will be calculated from the day of surgery to participant's recurrence or death with any cause
Time frame: 3 years
Adverse Events
Adverse Events of Chemotherapy
Time frame: 6 months
Plan to share: No — Research data can be available through contacting the PI
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
The First Affiliated Hospital of Zhengzhou University