Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma (NEWEAR)
Gastric Cancer
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
1.18 ≤ age ≤ 70, Male or Female; 2.Minimum life expectancy of 6 months; 3.Patients with localized, histologically confirmed gastric or gastroesophageal adenocarcinoma; 4.Patients must have a performance status of < 2 Eastern Cooperative Oncology Group (ECOG); 5.No prior major surgery of the stomach or radiation therapy to the stomach or immunotherapy or chemotherapy; 6.CT or MRI, endorectal ultrasonography (EUS), laparoscopic exploration are required to stage; 7.Without other benign diseases such as lung, kidney, liver infections; 8.Without participating other clinical trials; 9.Patient must sign an informed consent prior to study entry; 10.Patients must have adequate bone marrow function (defined as peripheral absolute granulocyte count of >1,500/µL, and platelet count of > 100,000/µL), adequate liver function (bilirubin <= 1.5 mg/dl), and adequate renal function (creatinine <= 1.5 mg/dl). 11)Patients without cardiac disease , severe uncontrolled diabetes, hypertension, cerebrovascular disease, or infection.
Exclusion Criteria:
- Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
- Female patients who planed to have a baby;
- Prior radiation therapy to the stomach, liver or kidney;
- Dysfunction of important organs such as liver, kidney or heart; 5.Abnormalities of mental status;
6.Active coronary artery disease; 7.Cardiac arrhythmia, and need to receive medication therapy; 8.Severe uncontrolled hypertension; 9.Active clinical serious infection; 10.The known human immunodeficiency virus (HIV) infection history; 11.The known central nervous system diseases, including brain metastatic tumors; 12.Patients have had clinical clear gastrointestinal bleeding in 6 months; 13.Drug abuse; 14.Swallowing difficulties for drugs; 15.Poor compliance; 16.Presence of concurrent or previous malignancies (except for cervical carcinoma in situ or basal cell carcinoma of the skin); 17.Presence of peritoneal metastasis, distant organs or lymph nodes metastasis; 18.Presence history of major surgery in the past three months; 19.Poor tolerability; 20.Prior history of medication; 21.allergy for chemotherapeutic drugs.
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
chemoradiotherapy, S1, oxaliplatin
chemoradiotherapy is given before surgical therapy,S1(Tegafur,Gimeracil and Oteracil Potassium Capsules) is given during radiation therapy and neoadjuvant chemotherapy, oxaliplatin is given during neoadjuvant chemotherapy.