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Trial Title:
Neoadjuvant Chemotherapy Plus Chemoradiation in Patients With Potentially Resectable Gastric Carcinoma
NCT ID:
NCT02024217
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Tegafur
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
S1，oxaliplatin，radiation
Description:
Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5;
Arm group label:
chemoradiotherapy, S1, oxaliplatin
Other name:
S1(Tegafur，Gimeracil and Oteracil Potassium Capsules)
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.
Criteria for 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:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Guichao Li, MD
Email:
11111230012@fudan.edu.cn
Contact backup:
Last name:
Xiaowen Liu, MD
Email:
liuxw1129@hotmail.com
Investigator:
Last name:
Zhen Zhang, MD
Email:
Principal Investigator
Start date:
March 2012
Completion date:
August 2015
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02024217
