Status:
RECRUITING
Chemoradiotherapy in Unresectable Esophageal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Esophageal Cancer
Chemoradiotherapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell ca...
Detailed Description
This Phase I/II clinical study is meticulously designed to assess the one-year local tumor control rate of a chemoradiotherapy regimen that combines albumin-bound paclitaxel and cisplatin in patients ...
Eligibility Criteria
Inclusion
- 18\~75 years
- 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
- With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04278287
Start Date
October 1 2019
End Date
December 1 2026
Last Update
December 13 2024
Active Locations (5)
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1
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China, 455001
2
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China, 410031
3
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210009
4
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029