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| Name | Class |
|---|---|
| Huadong Hospital | OTHER |
| Jiangsu Cancer Institute & Hospital | OTHER |
| Gansu Cancer Hospital | OTHER |
| The First Affiliated Hospital of Xiamen University |
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So far, there is no specific clinical guideline for elderly patients (>75 yr) with esophageal squamous cell carcinoma (ESCC). Patients with locally advanced ESCC were enrolled and randomly assigned to either definitive radiotherapy group (61.2Gy/34Fx） or the chemoradiotherapy group (50.4Gy/28Fx；Paclitaxel plus carboplatin). The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival.
Up to now, definitive radiotherapy was major treatment plan for elderly ESCC patients. However, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. Thus we design the clinical trail to answer the question.
Three hundred and twenty elderly patients with ESCC would be recruited. There are two stratification factors including 80 years old and lymph node metastasis. The patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (AUC=2) one cycle per week for five cycles.The primary end point was 3-year overall survival (OS). The second end points included life quality, radiation side effects and 3-yr cancer specific survival. The life quality questionnaire included QlQ-C30 and OES-18.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemoradiotherapy | Experimental | 50.4Gy/28Fx; Paclitaxel plus carboplatin |
|
| radiotherapy | Active Comparator | 61.2Gy/34Fx |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel plus carboplatin | Drug | Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival difference of definitive radiotherapy and chemoradiotherapy groups | The time between the start of the study treatment (Day 1) and death from any cause or last follow-up for patients alive at the end of the study. | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| difference of quality of life between different groups | Assess the quality of life through life quality questionnaire. | the period of treatment within 7 weeks and follow up time with an average of 3months |
| radiation side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuaile Zhao, doctor | Contact | 18017312534 | 021-64175590 | kuaile_z@sina.com |
| ying jia Deng, doctor | Contact | 18017312829 | dengjiaying3@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Kuaile Zhao, doctor | Fudan University | Study Chair |
| Xiangpeng Zheng, doctor | Huadong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Recruiting | Nanjing | Jiangsu | China |
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| OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| Taihe Hospital | OTHER |
| Wuxi No. 4 People's Hospital | OTHER |
| Ningbo No.2 Hospital | OTHER |
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| radiotherapy | Radiation | Different radiotherapy dose in different groups. |
|
Record the radiation side effects including acute and late side effects.
| acute side effects within 3 months, late side effects for 3 months later |
| cancer specific survival | The time between the start of the study treatment (Day 1) and death from tumor or last follow-up for patients alive at the end of the study. | 3-year |
| Huadong Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| Fudan Universtiy Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| 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 |
| 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 |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D013812 | Therapeutics |
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