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

Unresectable Esophageal Cancer Clinical Trial

Official title:

Efficacy and Safety of Neo-Radiochemotherapy Followed Surgery Compared With Definitive Radiochemotherapy in Patients With Initial Unresectable Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137679
• Other study ID #: TJESO-1
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2019
• Est. completion date: August 31, 2022

Study information

• Verified date: August 2019
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Tian Zhang, Doctor
• Phone: +862223341405
• Email: 839159994[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2022
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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.

2. Initial unresectable assessed by surgeon.

3. Patients able to tolerate surgery.

4. Untreated patients who have not received any antitumor therapy.

5. Life expectancy > 6 months.

6. Age: 18-70 years.

7. 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.

8. WHO PS(Performance Status): 0-1.

9. Patients who understood the study and gave signed informed consent.

Exclusion Criteria:

1. Patients who have already received antitumor therapy, including chemotherapy, radiotherapy or surgery.

2. Patients with hemorrhage or complicated hemorrhage.

3. Other uncontrollable patients who are not suitable for surgery.

4. Patients who deny to accept surgery.

5. Pregnant or lactating women.

6. Patients who agree without acknowledgement as a result of psychological, family or social factors.

7. Patients with CTCAE(Common Terminology Criteria Adverse Events Version 4.0) grade =2 peripheral neuropathy.

8. Patients who have ever had malignant tumors other than esophageal cancer.

9. Patients with a history of diabetes for >10 years with unsatisfactory control of blood glucose level.

10. Patients with serious heart, lung, liver or kidney dysfunction, hematopathy, immune system disease or cachexia who therefore cannot tolerate chemotherapy or surgery.

11. Patients with severe infection.

12. Patients with uncontrolled diabetes, random blood glucose > 200mg/L, fasting glucose >140mg/L.

13. Patients with other severe disease, such as myocardial infarction in the last 6 months.

14. Patients who participate in other clinical trials right now or in the last 4 weeks.

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Unresectable Esophageal Cancer

Intervention

Radiation:
• Definitive Radiochemotherapy
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day

Procedure:
• Neoadjuvant Radiochemotherapy followed by surgery
Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Tianjin Medical University Cancer Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy	5 years
Primary	Disease-free survival	Compare progression-free survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy.	3 years
Secondary	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment	grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.	5 years