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

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ClinicalTrials.gov Identifier: NCT02024217
Recruitment Status : Unknown
Verified December 2013 by Zhen Zhang, Fudan University.
Recruitment status was:  Recruiting
First Posted : December 31, 2013
Last Update Posted : December 31, 2013
Sponsor:
Information provided by (Responsible Party):
Zhen Zhang, Fudan University

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).

Condition or disease Intervention/treatment Phase
Gastric Cancer Radiation: S1,oxaliplatin,radiation Phase 2

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

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 Name: S1(Tegafur,Gimeracil and Oteracil Potassium Capsules)




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 6-8 Weeks ]
    6-8 weeks after Radiation therapy,we evaluate the lesion,if it is resectable,we will give surgical therapy,


Secondary Outcome Measures :
  1. safety and tolerability of the treatment regimen [ Time Frame: up to 10 weeks ]
    after neoadjuvant chemotherapy and chemoradiotherapy,we evaluate the side effects , and record the side effects


Other Outcome Measures:
  1. resection rate [ Time Frame: 6-8 Weeks ]
    6-8 weeks after Radiation therapy,we evaluate the lesion,if it is resectable,we will give surgical therapy,

  2. disease-free survival [ Time Frame: up to 36 months ]
    after surgical therapy,we followup the patients and stat the recurrence and death and calculate the disease-free survival

  3. over-all survival [ Time Frame: up to 36 months ]
    after surgical therapy,we followup the patients and stat the recurrence and death and calculate the over-all survival



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02024217


Contacts
Contact: Guichao Li, MD 862164175590 ext 1606 11111230012@fudan.edu.cn
Contact: Xiaowen Liu, MD liuxw1129@hotmail.com

Locations
China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Guichao Li, MD       11111230012@fudan.edu.cn   
Contact: Xiaowen Liu, MD       liuxw1129@hotmail.com   
Principal Investigator: Zhen Zhang, MD         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Zhen Zhang, MD Fudan University

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Zhen Zhang, Chairman of Department of Radiation Oncology Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT02024217     History of Changes
Other Study ID Numbers: LAGCCS001
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Tegafur
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action