Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
Recruiting now · Not applicable
Conditions studied: Esophageal Squamous Cell Carcinoma, Chemotherapy Effect, Side Effect of Drug
In brief
This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.
Key facts
- Study ID
- NCT05775419
- Run by
- The First Affiliated Hospital with Nanjing Medical University
- People needed
- 1216
- Starts
- 2021-06-30
- Expected to finish
- 2028-06-30
- Last updated by the study team
- 2023-03-20
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
- Esophageal squamous cell carcinoma proved by histopathology;
- Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
- According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
- ECOG 0-1; life expectancy > 6 months;
- No chemotherapy was used before selection;
- No history of radiotherapy;
- No surgical treatment;
- No serious allergic history;
- Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;
You may not qualify if…
- History of malignant tumors in other parts;
- Duplicate carcinoma of the esophagus;
- Pregnant or lactating patients;
- Fertility but not using contraceptive measures;
- Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
- During the active period of infectious diseases;
- Participate in other clinical trials at present or within four weeks before enrollment;
- Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
- After esophageal stent placement;
- Cases with perforation tendency;
- Have a history of organ transplantation.
- Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
- Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.
Where it is running
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
Full record on ClinicalTrials.gov
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