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Adjuvant Oxaliplatin Plus S-1 Versus Docetaxel Plus S-1 for Stage III Gastric Cancer

RecruitingPhase 3Ages 18 Years - 80 YearsAllRuijin Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. age 18 to 80 years old, male and female 2. histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction 3. patients underwent standard D2 gastrectomy and achieved R0 resection, and had no systemic therapy like neoadjuvant therapy 4. 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 5. with no evidence of metastatic disease 6. ECOG 0 to 1 7. Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) โ‰ฅ1.5x109/L, White blood count โ‰ฅ3.5x109/L, Platelets โ‰ฅ75x109/L, Hemoglobin (Hb) โ‰ฅ80g/L, ALT/AST โ‰ค2.5x ULN (for patient with liver metastasis ALT/AST โ‰ค5x ULN), Serum bilirubin โ‰ค1.5x ULN, Serum creatinine โ‰ค1.5x ULN. 8. Woman of childbearing age should contracept for at least one month before screening and commit to using contraception throughout the entire study period and for the specified time after the study ends. 9. Signed informed consent and willing to follow the study protocol Exclusion Criteria: 1. other primary malignancies, except for cured skin tumors or cervical carcinoma in situ 2. severe complications that may lead to an expected survival time less than 5 years 3. uncontrollable comorbidities, such as infectious disease, chronic diseases like hypertension, diabetes, heart diseases. 4. allergic to study medication 5. bowel obstruction or other conditions affecting oral administration 6. organ functions that cannot tolerate study treatment 7. other conditions that patients are unsuitable for this study assessed by the investigators
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What it tests

  • Oxaliplatin plus S-1
  • Docetaxel plus S-1
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Where

5 sites
Yuebei People's Hospital
Shaoguan, China
Fudan University Shanghai Cancer Center
Shanghai, China
Renji Hospital
Shanghai, China
Ruijin Hospital
Shanghai, China
Shanghai Tenth People's Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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