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

NCT04137679 | Unknown Phase 2 DMC

• 1 other identifier: TJESO-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Unresectable Esophageal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

  5 years

Study Arms (2)

Definitive Radiochemotherapy

EXPERIMENTAL

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

Radiation: Definitive Radiochemotherapy; Procedure: Neoadjuvant Radiochemotherapy followed by surgery

Neoadjuvant Radiochemotherapy followed by surgery

ACTIVE COMPARATOR

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.

Radiation: Definitive Radiochemotherapy; Procedure: Neoadjuvant Radiochemotherapy followed by surgery

Interventions

Definitive Radiochemotherapy RADIATION

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

Definitive Radiochemotherapy; Neoadjuvant Radiochemotherapy followed by surgery

Neoadjuvant Radiochemotherapy followed by surgery PROCEDURE

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.

Definitive Radiochemotherapy; Neoadjuvant Radiochemotherapy followed by surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Study Officials

• Qingsong Pang, Doctor

  Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Tian Zhang, Doctor

CONTACT

+862223341405; 839159994@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: November 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: August 31, 2022
• Last Updated: November 1, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)