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
Qualifiers
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
Treatments tested in this trial
- Oxaliplatin plus S-1
- Docetaxel plus S-1
Treatment groups
387 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov