A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer

Jing Jin, M.D.

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer; Neoadjuvant Therapy

Treatments: Procedure: Surgery; Drug: SOX; Radiation: SIB-IMRT; Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT04062058

LC2018L03

Details and patient eligibility

About

This prospective, single arm phase II study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma

Enrollment: 82 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N+M0
• No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
• No prior abdominal or pelvic radiotherapy
• Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
• Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
• Informed consent

Exclusion criteria

• Any prior chemotherapy or other cancer treatment prior to this protocol
• Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
• With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
• History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
• Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
• History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
• History of prior radiation to the abdomen
• Pregnant or lactating females

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

Total Neoadjuvant Chemoradiotherapy

Experimental group

Description:

Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery

Treatment:

Procedure: Surgery

Drug: SOX

Radiation: SIB-IMRT

Drug: S-1