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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    60
  • sponsor
    Tianjin Medical University Cancer Institute and Hospital
Updated on 23 January 2021

Summary

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.

Description

  1. Compare progression-free survival (PFS) and overall survival (OS) of definitive radiochemotherapy versus(VS) neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who down stage from inoperable to operable after neoadjuvant treatment;
  2. Compare the toxic and side effects of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete remission after neoadjuvant treatment;
  3. Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients.

Concurrent Radiochemotherapy: Radiotherapy, Intensity Modulation Radiation Therapy(IMRT), 40Gy; Chemotherapy, Docetaxel 25mg/m2+Cisplatin (25mg/m2), 1st/8th/15th/22nd day

Details
Condition Unresectable Esophageal Cancer
Treatment Definitive Radiochemotherapy, Neoadjuvant Radiochemotherapy followed by surgery
Clinical Study IdentifierNCT04137679
SponsorTianjin Medical University Cancer Institute and Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Thoracic esophageal cancer patients or esophagogastric junction cancer patients, with locally advanced unresectable tumor, clinically identified before treatment as T4bNxM0 or lymph node metastases (LNM)invading adjacent structures according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 8th ed
Initial unresectable assessed by surgeon
Patients able to tolerate surgery
Untreated patients who have not received any antitumor therapy
Life expectancy > 6 months
Age: 18-70 years
White blood cell count 4.010^9/L, ANC(absolute neutrophil count) 1.510^9/L, thrombocyte count 10010^9/L, hemoglobin 90 g/L; normal liver and kidney functions
WHO PS(Performance Status): 0-1
Patients who understood the study and gave signed informed consent

Exclusion Criteria

Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery
Patients with hemorrhage or complicated hemorrhage
Other uncontrollable patients who are not suitable for surgery
Patients who deny to accept surgery
Pregnant or lactating women
Patients who agree without acknowledgement as a result of psychological, family or social factors
Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade 2 peripheral neuropathy
Patients who have ever had malignant tumors other than esophageal cancer
Patients with a history of diabetes for >10 years with unsatisfactory control of blood glucose level
Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery
Patients with severe infection
Patients with uncontrolled diabetes, random blood glucose > 200mg/L, fasting glucose >140mg/L
Patients with other severe disease, such as myocardial infarction in the last 6 months
Patients who participate in other clinical trials right now or in the last 4 weeks
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