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

Primary Purpose

Gastric Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S1,oxaliplatin,radiation
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemoradiotherapy, S1, oxaliplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

R0 resection rate
6-8 weeks after Radiation therapy,we evaluate the lesion,if it is resectable,we will give surgical therapy,

Secondary Outcome Measures

safety and tolerability of the treatment regimen
after neoadjuvant chemotherapy and chemoradiotherapy,we evaluate the side effects , and record the side effects

Full Information

First Posted
April 5, 2013
Last Updated
December 25, 2013
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02024217
Brief Title
Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma
Acronym
NEWEAR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemoradiotherapy, S1, oxaliplatin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
S1,oxaliplatin,radiation
Other Intervention Name(s)
S1(Tegafur,Gimeracil and Oteracil Potassium Capsules)
Intervention Description
Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5;
Primary Outcome Measure Information:
Title
R0 resection rate
Description
6-8 weeks after Radiation therapy,we evaluate the lesion,if it is resectable,we will give surgical therapy,
Time Frame
6-8 Weeks
Secondary Outcome Measure Information:
Title
safety and tolerability of the treatment regimen
Description
after neoadjuvant chemotherapy and chemoradiotherapy,we evaluate the side effects , and record the side effects
Time Frame
up to 10 weeks
Other Pre-specified Outcome Measures:
Title
resection rate
Description
6-8 weeks after Radiation therapy,we evaluate the lesion,if it is resectable,we will give surgical therapy,
Time Frame
6-8 Weeks
Title
disease-free survival
Description
after surgical therapy,we followup the patients and stat the recurrence and death and calculate the disease-free survival
Time Frame
up to 36 months
Title
over-all survival
Description
after surgical therapy,we followup the patients and stat the recurrence and death and calculate the over-all survival
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Pregnant women are excluded from study entry due to the potential teratogenic effects of the study treatment; Female patients who planed to have a baby; Prior radiation therapy to the stomach, liver or kidney; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guichao Li, MD
Phone
862164175590
Ext
1606
Email
11111230012@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaowen Liu, MD
Email
liuxw1129@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guichao Li, MD
Email
11111230012@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Xiaowen Liu, MD
Email
liuxw1129@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19139439
Citation
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.
Results Reference
result
PubMed Identifier
29194623
Citation
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.
Results Reference
derived

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Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma

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