Status:
RECRUITING
Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Esophagus Cancer
Esophagogastric Junction Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these...
Eligibility Criteria
Inclusion
- ≥18 years；
- Esophageal or Esophagogastric cancer；
- Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th)；
- Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
- ECOG PS score: 0\~1；
- 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；
- Absence of medical records.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04821778
Start Date
January 1 2002
End Date
December 31 2025
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