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| Name | Class |
|---|---|
| Guangdong Provincial People's Hospital | OTHER |
| Massachusetts General Hospital | OTHER |
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To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemoradiotherapy | Patients who had chemoradiotherapy before surgery. |
| |
| Neoadjuvant chemotherapy | Patients who had chemotherapy before surgery. |
| |
| Surgery alone | Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemoradiotherapy | Combination Product | In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) | DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause | 5 years |
| R0 resection rate | R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction that was clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography were eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Herui Yao, PhD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Chair |
| Haiyu Zhou, PhD | Guangdong Provincial People's Hospital | Principal Investigator |
| Michael Lanuti, PhD | Massachusetts General Hospital of Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital of Harvard Medical School | Boston | Massachusetts | 01748 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32637899 | Derived | Zhou HY, Zheng SP, Li AL, Gao QL, Ou QY, Chen YJ, Wu ST, Lin DG, Liu SB, Huang LY, Li FS, Zhu HY, Qiao GB, Lanuti M, Yao HR, Yu YF. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study). EClinicalMedicine. 2020 Jun 27;24:100422. doi: 10.1016/j.eclinm.2020.100422. eCollection 2020 Jul. |
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The datasets used or analysed during the current study are available from the corresponding author on reasonable request.
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| Oesophagectomy | Procedure | Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth. |
|
| Neoadjuvant chemotherapy | Drug | In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes. |
|
| Baseline |
| Pathologic complete response (pCR) | pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens. | Baseline |
| 30-day postoperative or in-hospital mortality | 30 days |
| Guangdong Provincial People's Hospital |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| D016629 | Esophagectomy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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