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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04062058
• Other study ID #: LC2018L03
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2019
• Est. completion date: September 21, 2023

Study information

• Verified date: January 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Jing Jin, MD
• Phone: +8613601365130
• Email: jingjin1025[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: September 21, 2023
• Est. primary completion date: September 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Neoadjuvant Therapy
• Stomach Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Jing Jin, M.D.	Beijing Hope Run

Country where clinical trial is conducted

China, 

Outcome

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