Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRuijin Hospital
About this trial
This is a multicenter, open-label, phase 3, randomized, non-inferiority study aimed to investigate the effect on disease-free survival of adjuvant chemotherapy with oxaliplatin plus S-1 compared with adjuvant chemotherapy with docetaxel plus S-1 after D2 gastrectomy in patients with stage III gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18 to 80 years old, male and female
histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy
American Joint Committee on Cancer stage IIIA (T2N3a, T3N2, T4aN1, T4aN2, T4bN0), IIIB (T1N3b, T2N3b, T3N3a, T4aN3a, T4bN1, T4bN2), IIIC (T3N3b, T4aN3b, T4bN3a, T4bN3b), and has Lauren classification
Disqualifiers
other primary malignancies, except for cured skin tumors or cervical carcinoma in situ
severe complications that may lead to an expected survival time less than 5 years
uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases.
allergic to study medication
Trial design
Design model
Parallel
Treatments tested in this trial
Oxaliplatin plus S-1
DrugSOX group: eight 3-week cycles of intravenous oxaliplatin (130mg/m2 on day 1 for each cycle) with orally S-1 dose dependent on body surface area (\<1.24 m2, 40mg twice a day; 1.25-1.5 m2, 50mg twice a day; \>1.5m2 60mg twice a day, days 1 to 14 of each cycle).
Docetaxel plus S-1
DrugDS group: S-1 on days 1 to 14 of a 3-week cycle during the first cycle. During the second to seventh cycles, patients received intravenous infusion of docetaxel (40mg/m2) on day 1 of each cycle and S-1 on days 1 to 14 of a 3-week cycle. After the eighth cycle, treatment with S-1 continued on days 1 to 28 of 6-week cycles for up to 1 year.
Treatment groups
387 Participants
are divided into 2 treatment groupsGroup A: Oxaliplatin plus S-1Experimental treatment 1 intervention
Group B: Docetaxel plus S-1Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
3-year disease-free survival rate
Defined as the proportion of patients who remain free from recurrence of the original gastric cancer, development of a new gastric cancer, or death from any cause at 3 years after randomization.
Time frame
From randomization to 3 years after randomizationSecondary outcomes
1
5-year overall survival rate
Defined as the proportion of patients who remain survival at 5 years after randomization.
Time frame
From randomization to 5 years after randomization2
Safety profiles
Adverse events during treatment
Time frame
through treatment completion, an average of 6 months3
Recurrence sites
Organs involved in tumor metastasis and recurrence
Time frame
From randomization to 3 years after randomizationSponsors and contacts
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Source ClinicalTrials.gov