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出境医 / 临床实验 / Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
Study Description
Brief Summary:
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
| Condition or disease | Intervention/treatment |
|---|---|
| Radiotherapy Side Effect Chemotherapy Effect Oesophageal Carcinoma Effect of Drugs Safety Issues | Combination Product: Neoadjuvant chemoradiotherapy Procedure: Oesophagectomy Drug: Neoadjuvant chemotherapy |
Detailed Description:
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.
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 423 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study) |
| Actual Study Start Date : | November 14, 2018 |
| Actual Primary Completion Date : | December 1, 2019 |
| Actual Study Completion Date : | December 1, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
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Neoadjuvant chemoradiotherapy
Patients who had chemoradiotherapy before surgery.
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Combination Product: Neoadjuvant chemoradiotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
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Neoadjuvant chemotherapy
Patients who had chemotherapy before surgery.
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Drug: Neoadjuvant chemotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
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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.
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Procedure: Oesophagectomy
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.
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Outcome Measures
Primary Outcome Measures :
- Overall survival (OS) [ Time Frame: 5 years ]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.
Secondary Outcome Measures :
- Disease-free survival (DFS) [ Time Frame: 5 years ]DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause
- R0 resection rate [ Time Frame: Baseline ]R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin).
- Pathologic complete response (pCR) [ Time Frame: Baseline ]pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens.
- 30-day postoperative or in-hospital mortality [ Time Frame: 30 days ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
Inclusion Criteria:
- Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.
- Patients 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.
- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Exclusion Criteria:
- Patients had received any previous treatment for oesophageal cancer.
- Patients who were unsuitable for surgery because of comorbidities.
- Patients had evidence of distant metastatic disease by history and physical examination.
Contacts and Locations
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital of Harvard Medical School | |
| Boston, Massachusetts, United States, 01748 | |
| China, Guangdong | |
| Guangdong Provincial People's Hospital | |
| Guangzhou, Guangdong, China, 510000 | |
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University | |
| Guangzhou, Guangdong, China, 510000 | |
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangdong Provincial People's Hospital
Massachusetts General Hospital
Investigators
| Study Chair: | Herui Yao, PhD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |
| Principal Investigator: | Haiyu Zhou, PhD | Guangdong Provincial People's Hospital | |
| Principal Investigator: | Michael Lanuti, PhD | Massachusetts General Hospital of Harvard Medical School |
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 18, 2019 | |||||||||
| First Posted Date | July 22, 2019 | |||||||||
| Last Update Posted Date | May 29, 2020 | |||||||||
| Actual Study Start Date | November 14, 2018 | |||||||||
| Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Overall survival (OS) [ Time Frame: 5 years ] 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.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study） | |||||||||
| Official Title | Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study) | |||||||||
| Brief Summary | To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma. | |||||||||
| Detailed Description | 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. | |||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Not Provided | |||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | 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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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | 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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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
423 | |||||||||
| Original Actual Enrollment | Same as current | |||||||||
| Actual Study Completion Date | December 1, 2019 | |||||||||
| Actual Primary Completion Date | December 1, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 80 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | China, United States | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT04027543 | |||||||||
| Other Study ID Numbers | SYSEC-KY-KS-2019-068 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Herui Yao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |||||||||
| Study Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | |||||||||
| Verification Date | May 2020 | |||||||||
