Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
NCT ID: NCT03734952
Last Updated: 2023-09-25
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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RECRUITING
NA
537 participants
INTERVENTIONAL
2023-05-01
2029-01-01
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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Group A
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
Neoadjuvant Radiotherapy Program:
Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).
Neoadjuvant chemotherapy Program
Chemotherapy is delivered concomitantly and composed of two cycles of Docetaxel 60mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.
Esophagectomy program:
Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
Postoperative radiotherapy program
A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.
Group B
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program
Neoadjuvant Radiotherapy Program:
Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).
Neoadjuvant chemotherapy Program
Chemotherapy is delivered concomitantly and composed of two cycles of Docetaxel 60mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.
Esophagectomy program:
Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
Interventions
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Neoadjuvant Radiotherapy Program:
Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).
Neoadjuvant chemotherapy Program
Chemotherapy is delivered concomitantly and composed of two cycles of Docetaxel 60mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.
Esophagectomy program:
Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
Postoperative radiotherapy program
A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.
Eligibility Criteria
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Inclusion Criteria
2. Tumors of the esophagus are located in the thoracic cavity;
3. Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
4. Male or non pregnant female
5. Age is between 18 years and 65 years,
6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
7. Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
8. Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
9. Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
10. 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. Patients with another previous or current malignant disease；
4. Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
5. Age \>65 years;
6. Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
7. Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
8. Patients who refuse surgery after neoadjuvant chemotherapy;
9. Unsuitable to be enrolled in the trial in the opinion of the investigators
18 Years
65 Years
ALL
No
Sponsors
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Fujian Medical University Union Hospital
OTHER
Responsible Party
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Benhua Xu
Director,Radiation Oncology
Principal Investigators
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Benhua Xu, doctor
Role: PRINCIPAL_INVESTIGATOR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Benhua Xu
Role: primary
References
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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.
Yen YC, Chang JH, Lin WC, Chiou JF, Chang YC, Chang CL, Hsu HL, Chow JM, Yuan KS, Wu ATH, Wu SY. Effectiveness of esophagectomy in patients with thoracic esophageal squamous cell carcinoma receiving definitive radiotherapy or concurrent chemoradiotherapy through intensity-modulated radiation therapy techniques. Cancer. 2017 Jun 1;123(11):2043-2053. doi: 10.1002/cncr.30565. Epub 2017 Feb 2.
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.
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.
Cao XF, He XT, Ji L, Xiao J, Lv J. Effects of neoadjuvant radiochemotherapy on pathological staging and prognosis for locally advanced esophageal squamous cell carcinoma. Dis Esophagus. 2009;22(6):477-81. doi: 10.1111/j.1442-2050.2008.00910.x.
Chen Y, Hao D, Wu X, Xing W, Yang Y, He C, Wang W, Liu J, Wang J. Neoadjuvant versus adjuvant chemoradiation for stage II-III esophageal squamous cell carcinoma: a single institution experience. Dis Esophagus. 2017 Jul 1;30(7):1-7. doi: 10.1093/dote/dox016.
Stahl M, Walz MK, Riera-Knorrenschild J, Stuschke M, Sandermann A, Bitzer M, Wilke H, Budach W. Preoperative chemotherapy versus chemoradiotherapy in locally advanced adenocarcinomas of the oesophagogastric junction (POET): Long-term results of a controlled randomised trial. Eur J Cancer. 2017 Aug;81:183-190. doi: 10.1016/j.ejca.2017.04.027.
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.
Other Identifiers
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FujianUnionH-ESSC
Identifier Type: -
Identifier Source: org_study_id
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