- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03001596
Comparison Between NCRT and NCT Followed by MIE for Treatment of Locally Advanced Resectable ESCC (ESCCNCRTvNCT)
September 7, 2020 updated by: Shanghai Zhongshan Hospital
Neoadjuvant Chemoradiotherapy VS. Neoadjuvant Chemotherapy Followed by Minimally Invasive Esophagectomy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma(cT3-4aN0-1M0):A Multi-center Prospective Randomized Clinical Trial
The purpose of this study is to evaluate the outcomes of neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy on patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0).
Study Overview
Status
Completed
Detailed Description
It is a prospective randomized phase III clinical trial sponsored by Shanghai Zhongshan Hospital with other eight hospitals in China participating in.
264 patients with locally advanced resectable esophageal squamous cell carcinoma(cT3-4aN0-1M0) are recruited and randomly assigned into the neoadjuvant chemoradiotherapy group (NCRT group) and the neoadjuvant chemotherapy group (NCT group) according to the proportion of 1:1.The safety,efficacy of protocols and prognosis of patients are compared between the two regimens.
Study Type
Interventional
Enrollment (Actual)
264
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200032
- Shanghai Zhongshan Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Neoadjuvant chemoradiotherapy
Neoadjuvant chemoradiotherapy (NCRT) is performed followed by minimally invasive esophagectomy in enrolled patients.
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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.
Other Names:
After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Other Names:
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ACTIVE_COMPARATOR: Neoadjuvant chemotherapy
Neoadjuvant chemotherapy (NCT) is performed followed by minimally invasive esophagectomy in enrolled patients.
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After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
Other Names:
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall survival(OS)
Time Frame: Up to the date of death of any causes since the date of randomization, up to 36 months
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Up to the date of death of any causes since the date of randomization, up to 36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection rate
Time Frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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No vital tumor is presented at the proximal, distal, or circumferential resection margin, it is considered to be R0 resection.
If a vital tumor is shown at 1 mm or less from the proximal, distal, or circumferential resection margin, it is considered to be microscopically positive (R1).
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Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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Recurrence-free survival (RFS)
Time Frame: Up to the date of disease recurrence since the date of surgery, up to 36 months
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RFS is defined in resected patients who achieved an R0 or R1 resection as the time interval from surgery to the date of first recurrence (local, regional or distant) or death, whichever comes first.
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Up to the date of disease recurrence since the date of surgery, up to 36 months
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Progression-free survival(PFS)
Time Frame: Up to the date of disease recurrence since the date of randomization, up to 36 months
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Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).
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Up to the date of disease recurrence since the date of randomization, up to 36 months
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Pathological response rate(pCR)
Time Frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading.
The degree of histomorphologic regression is clarified into four categories as follows: grade 1, no evidence of vital residual tumor cells (pathological complete response); grade 2, less than 10% vital residual tumor cells; grade 3, 10 to 50%; and grade 4, more than 50%.
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Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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Positive lymph nodes' number
Time Frame: Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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According to pathological reports, record the number of positive lymph nodes
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Up to the date of pathological reports obtained since the date of randomization, up to 12 months
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Treatment related complications
Time Frame: Up to 1 month after surgery since the data of randomization, up to 13 months
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Number and severity of adverse events that are related to treatment of each patients, and hospital readmission.
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Up to 1 month after surgery since the data of randomization, up to 13 months
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Quality of life(QOL)
Time Frame: Up to the end of follow-up since the data of surgery, up to 36 months
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QOL is respectively evaluated at randomization and 1 month, 3 month, 6 month and yearly after surgery among patients by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-C30) and EORTC QLQ-OES18
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Up to the end of follow-up since the data of surgery, up to 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lijie Tan, MD, Shanghai Zhongshan Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V; Australasian Gastro-Intestinal Trials Group. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011 Jul;12(7):681-92. doi: 10.1016/S1470-2045(11)70142-5. Epub 2011 Jun 16.
- Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. doi: 10.1200/JCO.2013.53.6532. Epub 2014 Jun 30.
- 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.
- 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.
- Shen Y, Zhong M, Wu W, Wang H, Feng M, Tan L, Wang Q. The impact of tidal volume on pulmonary complications following minimally invasive esophagectomy: a randomized and controlled study. J Thorac Cardiovasc Surg. 2013 Nov;146(5):1267-73; discussion 1273-4. doi: 10.1016/j.jtcvs.2013.06.043. Epub 2013 Aug 28. Erratum In: J Thorac Cardiovasc Surg. 2014 Jan;147(1):544.
- Feng M, Shen Y, Wang H, Tan L, Zhang Y, Khan MA, Wang Q. Thoracolaparoscopic esophagectomy: is the prone position a safe alternative to the decubitus position? J Am Coll Surg. 2012 May;214(5):838-44. doi: 10.1016/j.jamcollsurg.2011.12.047. Epub 2012 Mar 13.
- Shen Y, Zhang Y, Tan L, Feng M, Wang H, Khan MA, Liang M, Wang Q. Extensive mediastinal lymphadenectomy during minimally invasive esophagectomy: optimal results from a single center. J Gastrointest Surg. 2012 Apr;16(4):715-21. doi: 10.1007/s11605-012-1824-7. Epub 2012 Jan 19.
- Wang H, Feng M, Tan L, Wang Q. Comparison of the short-term quality of life in patients with esophageal cancer after subtotal esophagectomy via video-assisted thoracoscopic or open surgery. Dis Esophagus. 2010 Jul;23(5):408-14. doi: 10.1111/j.1442-2050.2009.01025.x. Epub 2009 Nov 23.
- Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
- Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):134.
- Ychou M, Boige V, Pignon JP, Conroy T, Bouche O, Lebreton G, Ducourtieux M, Bedenne L, Fabre JM, Saint-Aubert B, Geneve J, Lasser P, Rougier P. Perioperative chemotherapy compared with surgery alone for resectable gastroesophageal adenocarcinoma: an FNCLCC and FFCD multicenter phase III trial. J Clin Oncol. 2011 May 1;29(13):1715-21. doi: 10.1200/JCO.2010.33.0597. Epub 2011 Mar 28.
- Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5.
- Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. doi: 10.1200/JCO.2009.22.2083. Epub 2009 Sep 21.
- Jang R, Darling G, Wong RK. Multimodality approaches for the curative treatment of esophageal cancer. J Natl Compr Canc Netw. 2015 Feb;13(2):229-38. doi: 10.6004/jnccn.2015.0029.
- Kumagai K, Rouvelas I, Tsai JA, Mariosa D, Klevebro F, Lindblad M, Ye W, Lundell L, Nilsson M. Meta-analysis of postoperative morbidity and perioperative mortality in patients receiving neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal and gastro-oesophageal junctional cancers. Br J Surg. 2014 Mar;101(4):321-38. doi: 10.1002/bjs.9418. Epub 2014 Feb 3.
- Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1.
- Luketich JD, Alvelo-Rivera M, Buenaventura PO, Christie NA, McCaughan JS, Litle VR, Schauer PR, Close JM, Fernando HC. Minimally invasive esophagectomy: outcomes in 222 patients. Ann Surg. 2003 Oct;238(4):486-94; discussion 494-5. doi: 10.1097/01.sla.0000089858.40725.68.
- Fabian T, Martin J, Katigbak M, McKelvey AA, Federico JA. Thoracoscopic esophageal mobilization during minimally invasive esophagectomy: a head-to-head comparison of prone versus decubitus positions. Surg Endosc. 2008 Nov;22(11):2485-91. doi: 10.1007/s00464-008-9799-x. Epub 2008 Mar 5.
- Bakhos C, Oyasiji T, Elmadhun N, Kent M, Gangadharan S, Critchlow J, Fabian T. Feasibility of minimally invasive esophagectomy after neoadjuvant chemoradiation. J Laparoendosc Adv Surg Tech A. 2014 Oct;24(10):688-92. doi: 10.1089/lap.2014.0118. Epub 2014 Sep 2.
- Warner S, Chang YH, Paripati H, Ross H, Ashman J, Harold K, Day R, Stucky CC, Rule W, Jaroszewski D. Outcomes of minimally invasive esophagectomy in esophageal cancer after neoadjuvant chemoradiotherapy. Ann Thorac Surg. 2014 Feb;97(2):439-45. doi: 10.1016/j.athoracsur.2013.09.042. Epub 2013 Nov 20.
- Burmeister BH, Thomas JM, Burmeister EA, Walpole ET, Harvey JA, Thomson DB, Barbour AP, Gotley DC, Smithers BM. Is concurrent radiation therapy required in patients receiving preoperative chemotherapy for adenocarcinoma of the oesophagus? A randomised phase II trial. Eur J Cancer. 2011 Feb;47(3):354-60. doi: 10.1016/j.ejca.2010.09.009.
- Li J, Shen Y, Tan L, Feng M, Wang H, Xi Y, Wang Q. Is minimally invasive esophagectomy beneficial to elderly patients with esophageal cancer? Surg Endosc. 2015 Apr;29(4):925-30. doi: 10.1007/s00464-014-3753-x. Epub 2014 Sep 24.
- Shen Y, Feng M, Tan L, Wang H, Li J, Xi Y, Wang Q. Thoracoscopic esophagectomy in prone versus decubitus position: ergonomic evaluation from a randomized and controlled study. Ann Thorac Surg. 2014 Sep;98(3):1072-8. doi: 10.1016/j.athoracsur.2014.04.107. Epub 2014 Jul 16.
- Li J, Shen Y, Tan L, Feng M, Wang H, Xi Y, Leng Y, Wang Q. Cervical triangulating stapled anastomosis: technique and initial experience. J Thorac Dis. 2014 May;6 Suppl 3(Suppl 3):S350-4. doi: 10.3978/j.issn.2072-1439.2014.02.06.
- Shen Y, Wang H, Feng M, Tan L, Wang Q. The effect of narrowed gastric conduits on anastomotic leakage following minimally invasive oesophagectomy. Interact Cardiovasc Thorac Surg. 2014 Aug;19(2):263-8. doi: 10.1093/icvts/ivu151. Epub 2014 May 20.
- Shen Y, Feng M, Khan MA, Wang H, Tan L, Wang Q. A simple method minimizes chylothorax after minimally invasive esophagectomy. J Am Coll Surg. 2014 Jan;218(1):108-12. doi: 10.1016/j.jamcollsurg.2013.09.014. Epub 2013 Nov 7.
- Wang H, Tan L, Feng M, Zhang Y, Wang Q. Comparison of the short-term health-related quality of life in patients with esophageal cancer with different routes of gastric tube reconstruction after minimally invasive esophagectomy. Qual Life Res. 2011 Mar;20(2):179-89. doi: 10.1007/s11136-010-9742-1. Epub 2010 Sep 21.
- Tang H, Wang H, Fang Y, Zhu JY, Yin J, Shen YX, Zeng ZC, Jiang DX, Hou YY, Du M, Lian CH, Zhao Q, Jiang HJ, Gong L, Li ZG, Liu J, Xie DY, Li WF, Chen C, Zheng B, Chen KN, Dai L, Liao YD, Li K, Li HC, Zhao NQ, Tan LJ. Neoadjuvant chemoradiotherapy versus neoadjuvant chemotherapy followed by minimally invasive esophagectomy for locally advanced esophageal squamous cell carcinoma: a prospective multicenter randomized clinical trial. Ann Oncol. 2022 Nov 15:S0923-7534(22)04730-5. doi: 10.1016/j.annonc.2022.10.508. Online ahead of print.
- 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.
- Tang H, Tan L, Shen Y, Wang H, Lin M, Feng M, Xu S, Guo W, Qian C, Liu T, Zeng Z, Hou Y, Yu Z, Jiang H, Li Z, Chen C, Lian C, Du M, Li H, Xie D, Yin J, Zhao N, Wang Q. CMISG1701: a multicenter prospective randomized phase III clinical trial comparing neoadjuvant chemoradiotherapy to neoadjuvant chemotherapy followed by minimally invasive esophagectomy in patients with locally advanced resectable esophageal squamous cell carcinoma (cT3-4aN0-1M0) (NCT03001596). BMC Cancer. 2017 Jun 28;17(1):450. doi: 10.1186/s12885-017-3446-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2017
Primary Completion (ACTUAL)
February 1, 2019
Study Completion (ACTUAL)
August 1, 2020
Study Registration Dates
First Submitted
December 17, 2016
First Submitted That Met QC Criteria
December 22, 2016
First Posted (ESTIMATE)
December 23, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 10, 2020
Last Update Submitted That Met QC Criteria
September 7, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
Other Study ID Numbers
- CMISG1701
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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