Clinical trial
A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy
Name
GXL-003
Description
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.
Trial arms
Trial start
2021-06-30
Estimated PCD
2025-06-30
Trial end
2028-06-30
Status
Recruiting
Treatment
Consolidation chemotherapy (4 courses)
Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen;
Arms:
Group B: radical chemoradiotherapy combined with consolidation chemotherapy group
Concurrent chemotherapy (2 courses)
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week\*2cycles; DDP 75mg/m2 ivgtt, d2, 3week\*2cycles;
Arms:
Group A: radical chemoradiotherapy group;
Size
1216
Primary endpoint
3-years overall survival (OS)
up to 3 years
5-years overall survival (OS)
up to 5 years
Eligibility criteria
Inclusion Criteria:
1. Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
2. Esophageal squamous cell carcinoma proved by histopathology;
3. Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
4. According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
5. ECOG 0-1; life expectancy \> 6 months;
6. No chemotherapy was used before selection;
7. No history of radiotherapy;
8. No surgical treatment;
9. No serious allergic history;
10. 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;
Exclusion Criteria:
1. History of malignant tumors in other parts;
2. Duplicate carcinoma of the esophagus;
3. Pregnant or lactating patients;
4. Fertility but not using contraceptive measures;
5. Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
6. During the active period of infectious diseases;
7. Participate in other clinical trials at present or within four weeks before enrollment;
8. Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
9. After esophageal stent placement;
10. Cases with perforation tendency;
11. Have a history of organ transplantation.
12. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;
13. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1216, 'type': 'ESTIMATED'}}
Updated at
2023-03-20
1 organization
2 products
3 indications
Product
Consolidation chemotherapyIndication
Esophageal squamous cell carcinomaIndication
Chemotherapy EffectIndication
Adverse Drug ReactionProduct
Concurrent chemotherapy