Chemotherapy Effect, Effect of Drugs, Oesophageal Carcinoma, Radiotherapy Side Effect, Safety Issues
Conditions
Keywords
Neoadjuvant chemoradiotherapy, Neoadjuvant chemotherapy, Resectable oesophageal carcinoma, Effective, Safety
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.
Interventions
PROCEDUREOesophagectomy
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.
COMBINATION_PRODUCTNeoadjuvant chemoradiotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
DRUGNeoadjuvant chemotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
Sponsors
Guangdong Provincial People's Hospital
Massachusetts General Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 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 | Baseline | R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin). |
| Pathologic complete response (pCR) | 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 | 30 days | — |
Countries
China, United States
Outcome results
None listed