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This is a prospective Randomized Phase â…¡ Trial Comparing Preoperative Chemoradiotherapy (Paclitaxel and carboplatin) Followed by Surgery to Surgery Followed by Postoperative Chemoradiotherapy (Paclitaxel and carboplatin) for Esophageal Cancer.
Patient Population:
Thoracic esophageal cancer able to tolerate tri-modality therapy; Clinical stage T3-4, N0-1, M0
Scheme:
Patients are randomized to 2 arms:
Arm A:
Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
Arm B:
Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Treatment | Experimental | Preoperative chemotherapy/radiotherapy |
|
| Adjuvant Treatment | Experimental | Postoperative chemotherapy/radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemoradiotherapy | Other | Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Scores of Quality of life | Assess the quality of life based on FACT-E. | 1 year |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Assess the safety and tolerability based on NCI CTC V4.0 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival | Three years disease free survival will be evaluated. | 3 years |
| Overall Survival | Three years overall survival will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weimin Mao, MD. | Contact | +86-571-88122032 | maowmzj1218@163.com | |
| Yaping Xu, MD. | Contact | +86-571-88122082 | xuyaping1207@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Weimin Mao, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Not yet recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D059186 | Chemoradiotherapy, Adjuvant |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D059248 | Chemoradiotherapy |
| D004358 | Drug Therapy |
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|
| Adjuvant chemoradiotherapy | Other | Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles. |
|
|
| 3 years |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D011878 |
| Radiotherapy |