NCT03734952

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
537

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
May 2023Jan 2029

First Submitted

Initial submission to the registry

October 26, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
4.5 years until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 25, 2023

Status Verified

September 1, 2023

Enrollment Period

5.7 years

First QC Date

October 26, 2018

Last Update Submit

September 22, 2023

Conditions

Radiation Oncology

Outcome Measures

Primary Outcomes (1)

  • overall survival

    The length of time from enrollment until the time of death

    From enrollment to 5 years after the end of treatment

Secondary Outcomes (3)

  • disease free survival

    From enrollment to 5 years after the end of treatment

  • local recurrence rate

    From enrollment to 5 years after the end of treatment

  • Side effects

    From enrollment to 12 weeks after end of the treatment

Study Arms (2)

Group A

EXPERIMENTAL

Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program+Postoperative radiotherapy program

Radiation: Neoadjuvant Radiotherapy Program:Drug: Neoadjuvant chemotherapy ProgramProcedure: Esophagectomy program:Radiation: Postoperative radiotherapy program

Group B

OTHER

Neoadjuvant Radiotherapy Program+Neoadjuvant chemotherapy Program+ Esophagectomy program

Radiation: Neoadjuvant Radiotherapy Program:Drug: Neoadjuvant chemotherapy ProgramProcedure: Esophagectomy program:

Interventions

Neoadjuvant Radiotherapy Program:RADIATION

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).

Group AGroup B
Neoadjuvant chemotherapy ProgramDRUG

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.

Group AGroup B
Esophagectomy program:PROCEDURE

Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy

Group AGroup B
Postoperative radiotherapy programRADIATION

A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.

Group A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26808342BACKGROUND

  • 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.

    PMID: 28152166BACKGROUND

  • 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.

    PMID: 21084184BACKGROUND

  • 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.

    PMID: 19139439BACKGROUND

  • 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.

    PMID: 19703071BACKGROUND

  • 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.

    PMID: 28475725BACKGROUND

  • 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.

    PMID: 28628843BACKGROUND

  • 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.

    PMID: 22646630BACKGROUND

Study Officials

  • Benhua Xu, doctor

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benhua Xu, doctor

CONTACT

+86-13696884375benhuaxu@163.com

Jianyuan Song, doctor

CONTACT

+86-13625045732songjianyuan@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director,Radiation Oncology

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 8, 2018

Study Start

May 1, 2023

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

September 25, 2023

Record last verified: 2023-09

Locations

CN(1)