Comparison Between NCRT and NCT Followed by MIE for Treat... | NCT03001596

Status Module

Name	Class
Fujian Medical University Union Hospital	OTHER
Tianjin Medical University Cancer Institute and Hospital	OTHER
Ruijin Hospital	OTHER
Shanghai Chest Hospital

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neoadjuvant chemoradiotherapy	Experimental	Neoadjuvant chemoradiotherapy (NCRT) is performed followed by minimally invasive esophagectomy in enrolled patients.	Procedure: Neoadjuvant Chemoradiotherapy Procedure: Minimally Invasive Esophagectomy
Neoadjuvant chemotherapy	Active Comparator	Neoadjuvant chemotherapy (NCT) is performed followed by minimally invasive esophagectomy in enrolled patients.	Procedure: Neoadjuvant Chemotherapy Procedure: Minimally Invasive Esophagectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neoadjuvant Chemoradiotherapy	Procedure	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.

Outcomes Module

Measure	Description	Time Frame
Overall survival(OS)		Up to the date of death of any causes since the date of randomization, up to 36 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival(PFS)	Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).	Up to the date of disease recurrence since the date of randomization, up to 36 months
Pathological response rate(pCR)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically-confirmed squamous cell carcinoma of the esophagus;
Tumors of the esophagus are located in the thoracic cavity;
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).
Age is between 18 years and 75 years,
Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
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 %.
Adequate respiratory function with FEV1≥1.2L, FEV1%≥50% and DLCO≥50% shown in pulmonary function tests.
Adequate bone marrow function (White Blood Cells >4x10^9 /L; Neutrophil >2.0×10^9 /L; Hemoglobin > 90 g/L; platelets>100x10^9 /L);
Adequate liver function (Total bilirubin <1.5x Upper Level of Normal (ULN); Aspartate transaminase(AST) and Alanine transaminase (ALT) <1.5x ULN);
Adequate renal function (Glomerular filtration rate (CCr) >60 ml/min; serum creatinine (SCr) ≤120 µmol/L)；
The patient has provided written informed consent and is able to understand and comply with the study;

Exclusion Criteria:

Patients with non-squamous cell carcinoma histology;
Patients with advanced inoperable or metastatic esophageal cancer;
Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition);
Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 7th Edition);
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.
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;
Pregnant or lactating women and fertile women who will not be using contraception during the trial;
Allergy to any drugs;
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;
Expected lack of compliance with the protocol.

Name	Affiliation	Role
Lijie Tan, MD	Shanghai Zhongshan Hospital	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Zhongshan Hospital		Shanghai	Shanghai Municipality	200032	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22668811	Background	Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.
19139439	Background	Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics