Back to resultsPostoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Primary Purpose
Radiation Oncology
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Neoadjuvant Radiotherapy Program:
Neoadjuvant chemotherapy Program
Esophagectomy program:
Postoperative radiotherapy program
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Oncology
Eligibility Criteria
Inclusion Criteria:
- Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;
- Tumors of the esophagus are located in the thoracic cavity;
- Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
- Male or non pregnant female
- Age is between 18 years and 65 years,
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
- Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
- Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
- Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
- 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;
- Patients with another previous or current malignant disease；
- Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
- Age >65 years;
- Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- Patients who refuse surgery after neoadjuvant chemotherapy;
- Unsuitable to be enrolled in the trial in the opinion of the investigators
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A
Group B
Arm Description
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program
Outcomes
Primary Outcome Measures
overall survival
The length of time from enrollment until the time of death
Secondary Outcome Measures
disease free survival
The length of time from enrollment until the time of progression of disease
local recurrence rate
The percent of the patient with local recurrence
Side effects
adverse events according to NCI CTCAE 4.0 criteria
Full Information
NCT ID
NCT03734952
First Posted
October 26, 2018
Last Updated
September 22, 2023
Sponsor
Fujian Medical University Union Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03734952
Brief Title
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Official Title
Prospective Randomized Controlled Trial of Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
January 1, 2029 (Anticipated)
Study Completion Date
January 1, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fujian Medical University Union Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective is to compare surgery with postoperative radiotherapy (PORT) versus surgery, in terms of the overall survival time (OS) in Stage II or III squamous cell esophageal carcinoma with neoadjuvant chemoradiotherapy(nCRT).
Detailed Description
Esophageal squamous cell carcinoma (ESCC) is a common type of esophageal carcinoma in China, which is characterized by rapid development and fatal prognosis in most patients. Neoadjuvant chemoradiotherapy (nCRT) has been explored for many years in western countries and Japan, and proved to get survival benefit, especially for locally advanced esophageal cancer. However, the recurrence is the major cause of treatment failure in patients with ESCC. Our hypothesis is that inadequate radiation dose leads to recurrence of ESCC with nCRT and PORT lower recurrence rate and improved OS. As is known, there are no any studies concentrating on PORT in ESCC with nCRT. Patients are randomly assigned to PORT (Group A) or without PORT (Group B) with a 1:1 allocation ratio. The primary outcome is OS assessed with a minimum follow-up of 60 months. Secondary outcomes are progression-free survival (PFS), recurrence-free survival (RFS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Oncology
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
537 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program
Arm Title
Group B
Arm Type
Other
Arm Description
Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program
Intervention Type
Radiation
Intervention Name(s)
Neoadjuvant Radiotherapy Program:
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Neoadjuvant chemotherapy Program
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy program:
Intervention Description
Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
Intervention Type
Radiation
Intervention Name(s)
Postoperative radiotherapy program
Intervention Description
A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.
Primary Outcome Measure Information:
Title
overall survival
Description
The length of time from enrollment until the time of death
Time Frame
From enrollment to 5 years after the end of treatment
Secondary Outcome Measure Information:
Title
disease free survival
Description
The length of time from enrollment until the time of progression of disease
Time Frame
From enrollment to 5 years after the end of treatment
Title
local recurrence rate
Description
The percent of the patient with local recurrence
Time Frame
From enrollment to 5 years after the end of treatment
Title
Side effects
Description
adverse events according to NCI CTCAE 4.0 criteria
Time Frame
From enrollment to 12 weeks after end of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must not have received any prior anticancer therapy Histologically-confirmed squamous cell carcinoma of the esophagus;
Tumors of the esophagus are located in the thoracic cavity;
Pre-treatment stageⅡ-Ⅲ (AJCC/UICC 8th Edition)
Male or non pregnant female
Age is between 18 years and 65 years,
Eastern Cooperative Oncology Group (ECOG) performance status 0-1 or Karnofsky performance status (KPS) of 70 or more;
Adequate bone marrow function (White Blood Cells ≥4x109 /L; Neutrophil ≥1.5×109 /L; Hemoglobin≥ 90 g/L; platelets≥100x109 /L);
Adequate liver function (Total bilirubin, Aspartate transaminase(AST) and Alanine transaminase (ALT) ≤2x Upper Level of Normal (ULN));
Adequate renal function (serum creatinine (SCr) ≤1.5 x ULN);
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;
Patients with another previous or current malignant disease；
Any patient with a significant medical condition which is thought unlikely to tolerate the therapies. Such as cardiac disease;
Age >65 years;
Pregnant or lactating female or people during the birth-period who refused to take contraceptives;
Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
Patients who refuse surgery after neoadjuvant chemotherapy;
Unsuitable to be enrolled in the trial in the opinion of the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benhua Xu, doctor
Phone
+86-13696884375
Email
benhuaxu@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianyuan Song, doctor
Phone
+86-13625045732
Email
songjianyuan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benhua Xu, doctor
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benhua Xu
12. IPD Sharing Statement
Citations:
PubMed Identifier
26808342
Citation
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.
Results Reference
background
PubMed Identifier
28152166
Citation
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.
Results Reference
background
PubMed Identifier
21084184
Citation
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.
Results Reference
background
PubMed Identifier
19139439
Citation
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.
Results Reference
background
PubMed Identifier
19703071
Citation
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.
Results Reference
background
PubMed Identifier
28475725
Citation
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.
Results Reference
background
PubMed Identifier
28628843
Citation
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.
Results Reference
background
PubMed Identifier
22646630
Citation
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.
Results Reference
background
Learn more about this trial
Postoperative Radiotherapy in Thoracic Esophageal Squamous Cell Carcinoma With Neoadjuvant Chemoradiotherapy
We'll reach out to this number within 24 hrs