Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma (NEWEAR)

Phase II Study of Neoadjuvant Chemotherapy Wtih S1+Oxaliplatin (SOX) Regimen Followed by Chemoradiation Concurrent With S-1 in Patients With Potentially Resectable Gastric Carcinoma

To investigate the feasibility, safety and tolerability of Preoperative Chemoradiation in Patients With Localized Gastric Cancer. Primary endpoint: R0 resection rate. Secondary endpoint: resection rate, pathological complete regression (pCR), effectiveness and safety of regime, disease free survival(DFS) and overall survival(OS).

Study Overview

• Status: Unknown
• Conditions: Gastric Cancer
• Intervention / Treatment: Radiation: S1，oxaliplatin，radiation

Detailed Description

The prognosis of gastric cancer is poor partially due to low R0 resection rate. Neoadjuvant chemoradiotherapy was reported to be effective in this setting by several phase II studies. The investigators aim to evaluate the efficacy and toxicity of neoadjuvant chemoradiotherapy in a prospective phase II study.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Guichao Li, MD; Phone Number: 1606 862164175590; Email: 11111230012@fudan.edu.cn
• Study Contact Backup: Name: Xiaowen Liu, MD; Email: liuxw1129@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Xiaowen Liu, MD; Email: liuxw1129@hotmail.com
      • Contact: Guichao Li, MD; Email: 11111230012@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment;
2. Female patients who planed to have a baby;
3. Prior radiation therapy to the stomach, liver or kidney;
4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Radiation: S1，oxaliplatin，radiation; Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5; Other Names: S1(Tegafur，Gimeracil and Oteracil Potassium Capsules)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 resection rate	6-8 weeks after Radiation therapy，we evaluate the lesion，if it is resectable，we will give surgical therapy，	6-8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety and tolerability of the treatment regimen	after neoadjuvant chemotherapy and chemoradiotherapy，we evaluate the side effects , and record the side effects	up to 10 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
resection rate	6-8 weeks after Radiation therapy，we evaluate the lesion，if it is resectable，we will give surgical therapy，	6-8 Weeks
disease-free survival	after surgical therapy，we followup the patients and stat the recurrence and death and calculate the disease-free survival	up to 36 months
over-all survival	after surgical therapy，we followup the patients and stat the recurrence and death and calculate the over-all survival	up to 36 months

Collaborators and Investigators

• Sponsor: Fudan University

Publications and helpful links

General Publications

• Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.
• Liu X, Li G, Long Z, Yin J, Zhu X, Sheng W, Huang D, Zhu H, Zhang Z, Cai H, Huang H, Zhao G, Zhou Y, Zhang Z, Wang Y. Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer. J Surg Oncol. 2018 Mar;117(4):692-698. doi: 10.1002/jso.24917. Epub 2017 Nov 30.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: April 5, 2013
• First Submitted That Met QC Criteria: December 25, 2013
• First Posted (Estimate): December 31, 2013

Study Record Updates

• Last Update Posted (Estimate): December 31, 2013
• Last Update Submitted That Met QC Criteria: December 25, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Oxaliplatin; Tegafur
• Other Study ID Numbers: LAGCCS001