A Phase II Study of Total Neoadjuvant Therapy for Locally Advanced Gastric Cancer
NCT ID: NCT04062058
Last Updated: 2022-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
82 participants
INTERVENTIONAL
2019-11-20
2023-09-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Total Neoadjuvant Chemoradiotherapy
Total neoadjuvant chemoradiotherapy arm receives intensity-modulated neoadjuvant chemoradiotherapy (45Gy in 25 fractions) concurrently with oral S-1(40-60mg/m2, orally twice daily every weekday) followed by six cycles of SOX neoadjuvant chemotherapy and surgery
SIB-IMRT
45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
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)
Surgery
Surgery, preferred D2 lymphadenectomy
Interventions
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SIB-IMRT
45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
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)
Surgery
Surgery, preferred D2 lymphadenectomy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Beijing Hope Run
OTHER
Jing Jin, M.D.
UNKNOWN
Responsible Party
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Jing Jin, M.D.
Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Shi JM, Li N, Jiang LM, Yang L, Wang SL, Song YW, Liu YP, Fang H, Lu NN, Qi SN, Chen B, Li YX, Zhao DB, Tang Y, Jin J. A prospective phase II clinical trial of total neoadjuvant therapy for locally advanced gastric cancer and gastroesophageal junction adenocarcinoma. Sci Rep. 2024 Mar 29;14(1):7522. doi: 10.1038/s41598-024-58177-6.
Shi J, Li N, Tang Y, Jiang L, Yang L, Wang S, Song Y, Liu Y, Fang H, Lu N, Qi S, Chen B, Li Z, Liu S, Wang J, Wang W, Zhu S, Yang J, Li Y, Zhao D, Jin J. Total neoadjuvant therapy for locally advanced gastric cancer and esophagogastric junction adenocarcinoma: study protocol for a prospective, multicenter, single-arm, phase II clinical trial. BMC Gastroenterol. 2022 Jul 28;22(1):359. doi: 10.1186/s12876-022-02440-5.
Li N, Xiang X, Zhao D, Wang X, Tang Y, Chi Y, Yang L, Jiang L, Jiang J, Shi J, Liu W, Fang H, Tang Y, Chen B, Lu N, Jing H, Qi S, Wang S, Liu Y, Song Y, Li Y, Zhang L, Jin J. Preoperative versus postoperative chemo-radiotherapy for locally advanced gastric cancer: a multicenter propensity score-matched analysis. BMC Cancer. 2022 Feb 26;22(1):212. doi: 10.1186/s12885-022-09297-7.
Other Identifiers
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LC2018L03
Identifier Type: -
Identifier Source: org_study_id
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