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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RECRUITING
PHASE1/PHASE2
105 participants
INTERVENTIONAL
2019-10-01
2026-12-31
Brief Summary
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Detailed Description
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The trial will enroll patients diagnosed with unresectable ESCC, a condition where surgical intervention is not feasible due to the tumor's location, size, or patient comorbidities. Participants will undergo a thorough nutritional assessment using the NRS2002 criteria, which evaluates factors such as weight loss, body mass index, dietary intake, and severity of disease to determine their nutritional risk score. This screening is crucial as it helps identify patients who may benefit from nutritional interventions, which could potentially improve their overall response to the treatment and quality of life.
Once enrolled, patients will receive a combination chemoradiotherapy of albumin-bound paclitaxel and cisplatin. Albumin-bound paclitaxel is chosen for its ability to improve the delivery and efficacy of paclitaxel, a chemotherapy drug, by enhancing its solubility and distribution within the body. Cisplatin, a platinum-based chemotherapy agent, is included due to its well-established efficacy in treating various cancers, including esophageal cancer. This combination aims to maximize tumor reduction while managing potential side effects.
The primary endpoint of the study is to determine the local tumor control rate at one year, which refers to the percentage of patients whose tumors have not progressed or recurred within the treated area during this period. Secondary endpoints include overall survival, progression-free survival, and assessment of treatment-related toxicity. Additionally, the study will monitor changes in patients' nutritional status and quality of life, aiming to provide comprehensive insights into the efficacy and safety of this chemoradiotherapy regimen.
Regular follow-ups and imaging studies, such as CT scans or PET scans, will be conducted to evaluate the tumor response and detect any signs of progression. Blood tests and other laboratory assessments will be performed periodically to monitor patients' overall health and manage any adverse effects promptly. The data collected from this study will contribute valuable information to the ongoing efforts to improve treatment outcomes for patients with unresectable esophageal squamous cell carcinoma.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Albumin-Bound Paclitaxel and Cisplatin based chemoradiotherapy
Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).
Radiotherapy
59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.
Albumin-Bound Paclitaxel
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
Cisplatin
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
Interventions
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Radiotherapy
59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.
Albumin-Bound Paclitaxel
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
Cisplatin
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)
* Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
* ECOG PS score: 0\~1
* NRS2002 score \<3
* Estimated survival time ≥3 months
* Normal organ and marrow function as defined below:
Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit
* Informed consent
Exclusion Criteria
* Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
* Existing active infection such as active tuberculosis and hepatitis
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of allergic reactions attributed to paclitaxel, albumin or cisplatin
* Participation in other clinical trials currently or within 4 weeks of selection
* Pregnant or lactating females
18 Years
75 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
Principal Investigators
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Xin Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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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Central Contacts
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Facility Contacts
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Xiaomin Wang, MD
Role: primary
Qin Xiao, MD
Role: primary
Cheng Chen, MD
Role: primary
Xiaolin Ge, MD
Role: primary
Xin Wang, MD
Role: primary
Other Identifiers
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19/325-2109
Identifier Type: -
Identifier Source: org_study_id