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NCT03600831CompletedPhase 2/3

Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 9 Jan 2024

Brief summary (registry, in English)

The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.

Status (registry)
Completed
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
434 (actual)
First submitted
3 Jul 2018
Start date
20 Aug 2018
Primary completion date
30 May 2022
Lead sponsor
Huai'an First People's Hospital
NCT number
NCT03600831

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 434
  • From 20 Aug 2018 to the primary completion date, 30 May 2022
  • 4 sites 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

  • previous treatment with chemotherapy or radiotherapy
  • greater than 3 months after surgery
  • patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease;
  • drug addiction, Alcoholism or AIDS;

Other illness

  • complete esophageal obstruction after surgery, esophageal perforation;
  • other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
  • uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
  • with clear chemotherapy drug allergy

Other

  • pregnant or breast-feeding women;
  • participation in other interventional clinical trials within 30 days;

Who the study is looking for

  • biopsy-confirmed esophageal squamous cell carcinoma
  • age ≤ 70 years old,
  • Karnofsky performance status ≥ 70,
  • R0 esophagectomy according to the pathological examination of the resected specimens,
  • postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
  • Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin \<1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1\>0.8 L;.
  • no previous treatment or severe complications
  • Written informed consent

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

Full criteria on ClinicalTrials.gov

Sites (4)

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

SiteCityCountrySite status
Chinese Peiple's Liberation Army No.82 Hospital
Coordinator of this site? Confirm its status
Huai'anChinaUnknown status
Huai'an second peiple's Hospital
Coordinator of this site? Confirm its status
Huai'anChinaUnknown status
Lianshui County Peoples Hospital
Coordinator of this site? Confirm its status
Huai'anChinaUnknown status
xuyi peiple's Hospital
Coordinator of this site? Confirm its status
XuchengChinaUnknown status

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