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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

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:

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.

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

NCT ID

NCT04137679

First Posted

October 22, 2019

Last Updated

October 29, 2019

Sponsor

Tianjin Medical University Cancer Institute and Hospital

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

Studies a U.S. FDA-regulated Device Product

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

Time Frame

5 years

Title

Disease-free survival

Description

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

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

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

pangqingsong@yahoo.com.cn

12. IPD Sharing Statement

Plan to Share IPD

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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