A Phase II Study of Chemoradiotherapy With Nimotuzumab in Unresectable Esophageal Cancer
NCT ID: NCT04207918
Last Updated: 2024-05-16
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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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2019-11-14
2023-06-30
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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Neoadjuvant Chemoradiotherapy（NCRT）
NCRT arm receives intensity-modulated radiotherapy concurrently with S-1（40-60/m2/d，orally twice a day） and nimotuzumab（400mg/d，by intravenous infusion once a week）.
Radiotherapy
44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.
Nimotuzumab
400mg, by intravenous infusion once a week in 4-6 weeks.
S-1
40-60mg/m2/d，orally twice a day concurrently with radiotherapy.
Interventions
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Radiotherapy
44.94Gy and 37.8Gy in 21 fractions to PGTV and PTV for neoadjuvant treatment. 59.92Gy and 50.4Gy in 28 fractions to PGTV and PTV for definitive treatment.
Nimotuzumab
400mg, by intravenous infusion once a week in 4-6 weeks.
S-1
40-60mg/m2/d，orally twice a day concurrently with radiotherapy.
Eligibility Criteria
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Inclusion Criteria
* Pathologically or cytologically proven esophageal squamous cell carcinomas in patients staged as T2-4N0-1M0-1b (AJCC 6th TNM staging, M1b limited to clavicular or celiac lymph node metastasis)
* Primary treatment accepted in Chinese Academy of Medical Sciences
* KPS ≥70
* NRS score ≥2
* Cervical or thoracic esophageal cancer histologically proved esophageal cell carcinoma
* Normal organ and marrow function as defined below:
Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 3,500 G/L; Neutrophil: greater than or equal to 1,500 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine within normal upper limits; BUN within normal upper limits; AST/ALT: less than or equal to 1.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; Alkaline phosphatase :less than or equal to 1.5 times the upper limit
* Informed consent
Exclusion Criteria
* Any prior chemotherapy or other cancer treatment prior to this protocol
* With any distant metastasis in liver, lung, bone, CNS or peritoneal transplantation
* History of allergic reactions attributed to contrast medium, similar chemical or biologic complex
* Existing esophageal fistula, perforation and cachexia
* Existing active infection such as active tuberculosis and hepatitis
* 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
* Participation in other clinical trials currently or within 4 weeks of selection
* Pregnant or lactating females
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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XIN WANG
Principal Investigator
Locations
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Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, , China
Countries
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Other Identifiers
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19/291-2075
Identifier Type: -
Identifier Source: org_study_id
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