Phase II/III Study Comparing Chemoradiotherapy With Radiotherapy in Elderly Patients With Esophageal or Esophagogastric Cancer - 3JECROG P-01
NCT ID: NCT02979691
Last Updated: 2020-07-21
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
350 participants
INTERVENTIONAL
2016-10-31
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SIB-IMRT
SIB-IMRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday).
SIB-IMRT
S1 based SIB-IMRT
S1 based SIB-IMRT receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (59.92Gy and 50.4Gy in 28 fractions) concurrently with oral S-1(40-60mg, orally twice daily, on every weekday) followed by four cycles of S-1 (40-60mg, orally twice daily, d1-14, every 3 weeks) as an adjuvant chemotherapy.
SIB-IMRT
S-1
Interventions
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SIB-IMRT
S-1
Eligibility Criteria
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Inclusion Criteria
* Esophageal or Esophagogastric cancer
* Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as IIa-IVb (UICC 2002, IVb only with supraclavicular or celiac trunk lymph nodes metastasis)
* Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3
* No distant metastasis other than supraclavicular lymph nodes
* No prior history of thoracic radiation
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 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
* With any distant metastasis out of regional lymphatic drainage or in liver,lung,bone,CNS,etc
* History of allergic reactions attributed to similar chemical or biologic complex to S-1
* With esophageal fistula, perforation, cachexia prior to treatment
* 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
* Pregnant or lactating females
70 Years
ALL
No
Sponsors
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Hebei Medical University Fourth Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Anyang Tumor Hospital
OTHER
The First Affiliated Hospital with Nanjing Medical University
OTHER
Affiliated Hospital of Hebei University
OTHER
Fujian Cancer Hospital
OTHER_GOV
Tengzhou Central People's Hospital
OTHER_GOV
The First Affiliated Hospital of Zhengzhou University
OTHER
The Affiliated Hospital of Inner Mongolia Medical University
OTHER
Sichuan Cancer Hospital and Research Institute
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Zefen Xiao
Dr.
Locations
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Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, , China
Countries
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References
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Wang X, Han W, Zhang W, Wang X, Ge X, Lin Y, Zhou H, Hu M, Wang W, Liu K, Lu J, Qie S, Zhang J, Deng W, Wang L, Han C, Li M, Zhang K, Li L, Wang Q, Shi H, Yu Z, Zhao Y, Sun X, Shi Y, Pang Q, Zhou Z, Liang J, Chen D, Feng Q, Bi N, Zhang T, Deng L, Wang W, Liu W, Wang J, Zhai Y, Wang J, Chen W, Chen J, Xiao Z; Jing-Jin-Ji Esophageal and Esophagogastric Cancer Radiotherapy Oncology Group (3JECROG). Effectiveness of S-1-Based Chemoradiotherapy in Patients 70 Years and Older With Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2312625. doi: 10.1001/jamanetworkopen.2023.12625.
Wang X, Ge X, Wang X, Zhang W, Zhou H, Lin Y, Qie S, Hu M, Wang W, Liu K, Pang Q, Li M, Chen J, Liu M, Zhang K, Li L, Shi Y, Deng W, Li C, Ni W, Chang X, Han W, Deng L, Wang W, Liang J, Bi N, Zhang T, Liu W, Wang J, Zhai Y, Feng Q, Chen D, Zhou Z, Zhao Y, Sun X, Xiao Z. S-1-Based Chemoradiotherapy Followed by Consolidation Chemotherapy With S-1 in Elderly Patients With Esophageal Squamous Cell Carcinoma: A Multicenter Phase II Trial. Front Oncol. 2020 Aug 28;10:1499. doi: 10.3389/fonc.2020.01499. eCollection 2020.
Li C, Wang X, Wang X, Han C, Wang P, Pang Q, Chen J, Sun X, Wang L, Zhang W, Lin Y, Ge X, Zhou Z, Ni W, Chang X, Liang J, Deng L, Wang W, Zhao Y, Xiao Z. A multicenter phase III study comparing Simultaneous Integrated Boost (SIB) radiotherapy concurrent and consolidated with S-1 versus SIB alone in elderly patients with esophageal and esophagogastric cancer - the 3JECROG P-01 study protocol. BMC Cancer. 2019 Apr 29;19(1):397. doi: 10.1186/s12885-019-5544-1.
Other Identifiers
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3JECROG P-01
Identifier Type: -
Identifier Source: org_study_id
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