Comparison Between NCRT and NCT Followed by MIE for Treatment of Locally Advanced Resectable ESCC
NCT ID: NCT03001596
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
264 participants
INTERVENTIONAL
2017-01-31
2020-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy (NCRT) is performed followed by minimally invasive esophagectomy in enrolled patients.
Neoadjuvant Chemoradiotherapy
Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
Minimally Invasive Esophagectomy
After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Neoadjuvant chemotherapy
Neoadjuvant chemotherapy (NCT) is performed followed by minimally invasive esophagectomy in enrolled patients.
Neoadjuvant Chemotherapy
Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
Minimally Invasive Esophagectomy
After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Interventions
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Neoadjuvant Chemoradiotherapy
Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
Neoadjuvant Chemotherapy
Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
Minimally Invasive Esophagectomy
After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Tumors of the esophagus are located in the thoracic cavity;
3. Pre-treatment stage as cT3-4aN0-1M0 (AJCC/UICC 7th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization).
4. Age is between 18 years and 75 years,
5. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
6. Adequate cardiac function. All patients should perform ECG, and those with a cardiac history or ECG abnormality should perform echocardiography with the left ventricular ejection fraction \> 50 %.
7. Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests.
8. Adequate bone marrow function (White Blood Cells \>4x10\^9 /L; Neutrophil \>2.0×10\^9 /L; Hemoglobin \> 90 g/L; platelets\>100x10\^9 /L);
9. Adequate liver function (Total bilirubin \<1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) \<1.5x ULN);
10. Adequate renal function (Glomerular filtration rate (CCr) \>60 ml/min; serum creatinine (SCr) ≤120 µmol/L)；
11. The patient has provided written informed consent and is able to understand and comply with the study;
Exclusion Criteria
2. Patients with advanced inoperable or metastatic esophageal cancer;
3. Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition);
4. Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 7th Edition);
5. Patients with another previous or current malignant disease which is likely to interfere with treatment or the assessment of response in the judgement of the local surgical investigator.
6. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease (e.g. symptomatic coronary artery disease or myocardial infarction within last 12 months), clinically-significant lung disease, clinically-significant bone marrow, liver, renal function disorder;
7. Pregnant or lactating women and fertile women who will not be using contraception during the trial;
8. Allergy to any drugs;
9. Participation in another intervention clinical trial with interference to the chemotherapeutic or chemoradiotherapeutic intervention during this study or during the last 30 days prior to informed consent;
10. Expected lack of compliance with the protocol.
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
Ruijin Hospital
OTHER
Shanghai Chest Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Changzhi Medical College
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Peking University Cancer Hospital and Institute
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Lijie Tan, MD
Role: STUDY_DIRECTOR
Shanghai Zhongshan Hospital
Locations
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Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Wang H, Tang H, Fang Y, Tan L, Yin J, Shen Y, Zeng Z, Zhu J, Hou Y, Du M, Jiao J, Jiang H, Gong L, Li Z, Liu J, Xie D, Li W, Lian C, Zhao Q, Chen C, Zheng B, Liao Y, Li K, Li H, Wu H, Dai L, Chen KN. Morbidity and Mortality of Patients Who Underwent Minimally Invasive Esophagectomy After Neoadjuvant Chemoradiotherapy vs Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Surg. 2021 May 1;156(5):444-451. doi: 10.1001/jamasurg.2021.0133.
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Related Links
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American society of clinical oncology
American society of clinical oncology
Wolters kluwer
American society of clinical oncology
Other Identifiers
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CMISG1701
Identifier Type: -
Identifier Source: org_study_id
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