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

NCT04062058 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-01-24

No results posted yet for this study

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

Conditions

Interventions

RADIATION

SIB-IMRT

45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target

DRUG

S-1

40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment

DRUG

SOX

SOX (S-1: 40\~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)

PROCEDURE

Surgery

Surgery, preferred D2 lymphadenectomy

Sponsors & Collaborators

  • Beijing Hope Run

    collaborator OTHER

  • Jing Jin, M.D.

    lead UNKNOWN

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-20
Primary Completion
2022-09-21
Completion
2023-09-21

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04062058 on ClinicalTrials.gov