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

Primary Purpose

Unresectable Esophageal Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Definitive Radiochemotherapy
Neoadjuvant Radiochemotherapy followed by surgery
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Esophageal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Radiation Oncology, Tianjin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Definitive Radiochemotherapy

Neoadjuvant Radiochemotherapy followed by surgery

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 22, 2019
Last Updated
October 29, 2019
Sponsor
Tianjin Medical University Cancer Institute and Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04137679
Brief Title
Efficacy and Safety of Neo-CRT Followed Surgery Compared With Definitive CRT in Patients With Initial Unresectable ESO
Official Title
Efficacy and Safety of Neo-Radiochemotherapy Followed Surgery Compared With Definitive Radiochemotherapy in Patients With Initial Unresectable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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; 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; 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Definitive Radiochemotherapy
Arm Type
Experimental
Arm Description
Concurrent Radiochemotherapy: Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day.
Arm Title
Neoadjuvant Radiochemotherapy followed by surgery
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Definitive Radiochemotherapy
Intervention Description
Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel (25mg/m2)+Cisplatin (25mg/m2) 1st/8th/15th/22nd day
Intervention Type
Procedure
Intervention Name(s)
Neoadjuvant Radiochemotherapy followed by surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
Compare overall survival of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection for esophageal cancer patients who achieved clinical complete response after neoadjuvant radiochemotherapy
Time Frame
5 years
Title
Disease-free survival
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Description
grade 3 or 4 toxicity of leukocytes, febrile neutropenia, thrombocytes, hemoglobin, nausea/vomiting, diarrhea, stomatitis, esophagitis, cardiovascular.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 ≥4.0×10^9/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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tian Zhang, Doctor
Phone
+862223341405
Email
839159994@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingsong Pang, Doctor
Organizational Affiliation
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Radiation Oncology, Tianjin Medical University Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
QING SONG PANG, M.D
Phone
+86-22-23340123-1314
Email
pangqingsong@yahoo.com.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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