Chemotherapy Effect, Esophageal Squamous Cell Carcinoma, Side Effect of Drug
Conditions
Brief summary
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.
Detailed description
Test grouping: Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group; Specific chemotherapy regimens: Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week\*2cycles; DDP 75mg/m2 ivgtt, d2, 3week\*2cycles; 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; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation. Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life
Interventions
COMBINATION_PRODUCTConsolidation 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;
COMBINATION_PRODUCTConcurrent chemotherapy (2 courses)
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week\*2cycles; DDP 75mg/m2 ivgtt, d2, 3week\*2cycles;
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-years overall survival (OS) | up to 3 years | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. |
| 5-years overall survival (OS) | up to 5 years | Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-year progression-free survival (PFS) | up to 3 years | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death. |
| Objective response rate (ORR) Objective response rate (ORR) | through study completion, an average of 36 month | Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission |
| 5-year progression-free survival (PFS) | up to 5 years | The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death. |
Countries
China
Contacts
Primary ContactXiaolin GE, MM
Outcome results
None listed