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NCT05775419Recruiting

Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy

Source: ClinicalTrials.gov · Last updated 20 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1216 (estimated)
First submitted
7 Sept 2022
Start date
30 Jun 2021
Primary completion date
30 Jun 2025
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
NCT number
NCT05775419

What you commit to

  • Study type: Interventional
  • Planned participants: 1216
  • From 30 Jun 2021 to the primary completion date, 30 Jun 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participate in other clinical trials at present or within four weeks before enrollment;
  • Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);
  • Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Other illness

  • History of malignant tumors in other parts;
  • Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;
  • During the active period of infectious diseases;
  • Cases with perforation tendency;
  • Have a history of organ transplantation.

Other

  • Duplicate carcinoma of the esophagus;
  • Pregnant or lactating patients;
  • Fertility but not using contraceptive measures;
  • After esophageal stent placement;
  • Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;

Who the study is looking for

  • Age 18-70 years old, not limited to male or female; at least able to take liquid diet;
  • Esophageal squamous cell carcinoma proved by histopathology;
  • Esophageal squamous cell carcinoma that is inoperable or refuses surgery,
  • According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;
  • ECOG 0-1; life expectancy \> 6 months;
  • No chemotherapy was used before selection;
  • No history of radiotherapy;
  • No surgical treatment;
  • No serious allergic history;
  • Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.