Comparing two treatment approaches for esophageal squamous cell carcinoma
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
This study is testing whether adding extra chemotherapy to standard treatment can help people with inoperable esophageal squamous cell carcinoma live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1216 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05775419 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a phase III, multicenter, prospective randomized controlled study that evaluates the effectiveness of radical chemoradiotherapy versus radical chemoradiotherapy combined with consolidation chemotherapy in patients with inoperable esophageal squamous cell carcinoma. Participants will be assigned to one of two groups: one receiving only chemoradiotherapy and the other receiving chemoradiotherapy followed by additional chemotherapy. The study aims to compare survival rates and side effects over a period of time, focusing on both overall survival and progression-free survival. The chemotherapy regimens include specific drugs administered in a structured manner, and the study will also assess the quality of life of participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with inoperable esophageal squamous cell carcinoma who have not undergone prior chemotherapy or radiotherapy.
Not a fit: Patients with a history of other malignancies, those who have undergone previous treatments for esophageal cancer, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve survival rates and quality of life for patients with esophageal squamous cell carcinoma.
How similar studies have performed: Other studies have shown promising results with similar chemoradiotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiaolin GE, MM
- Email: doctorsxl@163.com
- Phone: 13951818797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.