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NCT04137679

Efficacy and Safety of Neo-CRT Followed Surgery Compared With Definitive CRT in Patients With Initial Unresectable ESO

Status unknown Phase 2 Last updated 1 November 2019
What this trial tests

Phase 2 trial testing Definitive Radiochemotherapy in Unresectable Esophageal Cancer in 60 participants. Status unknown.

Timeline
1 November 2019
Primary endpoint
1 January 2020
31 August 2022

Quick facts

Lead sponsorTianjin Medical University Cancer Institute and Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment60
Start date1 November 2019
Primary completion1 January 2020
Estimated completion31 August 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

Adults 18 to 70, any sex, with Unresectable Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Definitive chemoradiotherapy(CRT) has been regarded as a standard of care for patients with unresectable locally advanced esophageal cancer. Patients who are sensitive to CRT can achieve significantly down staging. Whether this part of patients could benefit from further surgical treatment remains unknown. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive CRT versus neo-CRT plus radical resection in patients who achieved down staging after neo-CRT for stage T4NxM0 esophageal Cancer.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A retrospective study comparing definitive chemoradiotherapy vs. chemoradiotherapy followed by surgery in T4 esophageal squamous cell carcinoma patients who were downstaged after neochemoradiotherapy.
    Zhang T, Guo Z, Chen X, Dong J, et al · · 2022 · cited 2× · PMID 35999608 · DOI 10.1186/s13014-022-02116-0

Verify or expand the search:

Other trials of Definitive Radiochemotherapy

Trials testing the same drug.

Other recruiting trials for Unresectable Esophageal Cancer

Currently open trials in the same condition.

Other Tianjin Medical University Cancer Institute and Hospital trials

Trials by the same sponsor.

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