Status:
UNKNOWN
Efficacy and Safety of Neo-CRT Followed Surgery Compared With Definitive CRT in Patients With Initial Unresectable ESO
Lead Sponsor:
Tianjin Medical University Cancer Institute and Hospital
Conditions:
Unresectable Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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 ≥4.0×10\^9/L, ANC(absolute neutrophil count) ≥1.5×10\^9/L, thrombocyte count ≥100×10\^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
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04137679
Start Date
November 1 2019
End Date
August 31 2022
Last Update
November 1 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060