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

Phase 2

• Conditions: Gastric Cancer; Neoadjuvant Therapy
• Interventions: Radiation: SIB-IMRT; Drug: S-1; Drug: SOX; Procedure: Surgery

• Registration Number: NCT04062058
• Lead Sponsor: Jing Jin, M.D.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-18
• Study First Submitted QC: 2019-08-18
• Study First Posted: 2019-08-20
• Study Start: 2019-11-20
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-01-24
• Primary Completion: 2022-09-21
• Study Completion: 2023-09-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Total Neoadjuvant Chemoradiotherapy	SOX	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
Total Neoadjuvant Chemoradiotherapy	Surgery	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
Total Neoadjuvant Chemoradiotherapy	SIB-IMRT	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
Total Neoadjuvant Chemoradiotherapy	S-1	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

Primary Outcome Measures

Name	Time	Method
PCR rate	6-8 months	Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under telemicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).

Secondary Outcome Measures

Name	Time	Method
Acute chemotherapy/Chemoradiotherapy toxicities	6-8 months	chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.
R0 resection rate	6-8 months	The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after total neoadjuvant therapy.
surgery complications	6-8 months	During hospital stay and within the first 30 days after completion of surgery.
Tumor down-staging	6-8 months	Down-staging was considered as any stage reduction between clinical and pathologic stage.

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC); 🇨🇳 Beijing, China