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NCT05327517Recruiting

Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial

Source: ClinicalTrials.gov · Last updated 14 Apr 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
192 (estimated)
First submitted
7 Apr 2022
Start date
10 Apr 2022
Primary completion date
31 Dec 2028
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT05327517

What you commit to

  • Study type: Interventional
  • Planned participants: 192
  • From 10 Apr 2022 to the primary completion date, 31 Dec 2028
  • 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.

Other illness

  • Without other malignancies;
  • With mental diseases;
  • With hemorrhagic disease;
  • Has a history of allergy to paclitaxel or cisplatin

Other

  • Inoperable patients;
  • Pregnant or lactating women;

Who the study is looking for

  • Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
  • Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
  • Aged 18-75 years;
  • Without any contraindication of operation;
  • Hemoglobin \>=90 g/L; Leukocytes \>=4.0x10\^9/L; Absolute neutrophil count \>=1.5x10\^9/L; Platelet \>=100x10\^9/L;Total bilirubin \<=1.5 ULN; ALT \<=2.5 ULN; AST \<=2.5 ULN; Serum creatinine \<=1.5 ULN or creatinine clearance rate \>=50 mL/min (Cocheroft-Gault);INR \<=1.5 ULN; APTT \<=1.5 ULN;
  • Without other malignancies;
  • Expected R0 resection;
  • ECOG PS 0-1;
  • Volunteered to participate in the study, signed the informed consent form.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Cancer Hospital, Chinese Academy of Medical Sciences
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

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