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A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemotherapy | Experimental | Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles. |
|
| Chemoradiotherapy | Experimental | 5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles |
|
| Surgery alone | No Intervention | Surgery alone, no adjuvant treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant treatment | Combination Product | adjuvant treatments include chemotherapy or chemoradiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | overall survival rate of each arms | 3-year overall survival |
| Overall Survival | overall survival rate of each arms | 5-year overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | Disease free survival rate of each arms | 3-year disease free survival |
| Disease Free Survival | Disease free survival rate of each arms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zheng, MD | Contact | +8659186218408 | 8408 | lacustrian@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun Chen, MD | Fujian Medical University Union Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 5-year disease free survival |
| Adverse Events | Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE) | 1 year |
| Scores of Quality of Life | Assess the quality of life based on EORTC QLQ-C30 and OES18 | 5 years |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |