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Trial Title:
Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC
NCT ID:
NCT05775419
Condition:
Esophageal Squamous Cell Carcinoma
Chemotherapy Effect
Side Effect of Drug
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Drug-Related Side Effects and Adverse Reactions
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Consolidation chemotherapy (4 courses)
Description:
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;
Arm group label:
Group B: radical chemoradiotherapy combined with consolidation chemotherapy group
Intervention type:
Combination Product
Intervention name:
Concurrent chemotherapy (2 courses)
Description:
Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2
ivgtt, d2, 3week*2cycles;
Arm group label:
Group A: radical chemoradiotherapy group;
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Nanjing Medical University
Address:
City:
Nanjing
Zip:
210009
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaolin Ge, PhD
Phone:
13951818797
Email:
doctorsxl@163.com
Start date:
June 30, 2021
Completion date:
June 30, 2028
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05775419
