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A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer

Primary Purpose

Stage II Esophageal Cancer, Stage III Esophageal Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Definitive Radiochemotherapy

Neoadjuvant Radiochemotherapy

About this trial

This is an interventional treatment trial for Stage II Esophageal Cancer

Eligibility Criteria

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

Inclusion Criteria:

Thoracic esophageal cancer patients or esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 7th ed.
Untreated patients who have not received any antitumor therapy
Life expectancy >6 months
Age: 18-70 years
White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/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
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
Others.

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

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

Secondary Outcome Measures

Progression-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.

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.

Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer

In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected.

Comparison between gross tumor volume (GTV) delineated with ultrasonic endoscopically placed titanium clips and GTV with conventional contouring method in thoracic esophageal cancer

patients undergo titanium clips placement on tumor boundaries under ultrasonic endoscopy before radiotherapy CT simulation. According to the clips, the reference GTVs are contoured by one experienced radiation oncologist. With the help of Eclipse treatment planning system, clips on CT are concealed. Two other radiation oncologists of expertise in oesophageal cancer delineate GTVs, defined as conventional GTVs, on the basis of endoscopy and oesophageal barium radiography. The two sets of GTVs are compared and analysed.

Determination of internal target volume (ITV) of thoracic esophageal cancer by evaluating movement of ultrasonic endoscopically placed titanium clips, with or without swallowing, during radiotherapy simulation

after titanium clips placement adjacent to esophageal cancer under ultrasonic endoscopy, clips movements in different borders and different directions are observed during radiotherapy simulation to determine the ITV of esophageal cancer, with or without swallowing.

Full Information

NCT ID

NCT02959385

First Posted

October 29, 2016

Last Updated

July 13, 2017

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02959385

Brief Title

A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer

Official Title

A Phase II Trial to Compare Efficacy and Safety of Definitive Radiochemotherapy VS Neoadjuvant Radiochemotherapy Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Stage II-III Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced oesophageal cancer. Many studies suggest that definitive Radiochemotherapy(CRT) has similar efficacy as neoadjuvant chemoradiotherapy plus surgery for esophageal cancers who respond to chemoradiation. Herein, a single center prospective randomized phase II clinical trial will be carried out to compare efficacy and safety of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection in patients who achieved clinical complete response(CCR) after neoadjuvant radiochemotherapy for stage II-III 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 achieved clinical complete response 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; Compare the relationship and consistency between pathological complete response of endoscopic biopsy specimens after neoadjuvant treatment and pathological complete response of surgical specimens in neoadjuvant radiochemotherapy plus radical resection group; Assess impact of definitive radiochemotherapy versus neoadjuvant radiochemotherapy plus radical resection on quality of life of patients. Clinical Complete Response After Neoadjuvant Treatment: Endoscope biopsy pathologic diagnosis indicate pathologic complete response after Neoadjuvant treatment; upper gastrointestinal/chest CT and symptom assessment indicate clinical complete response after Neoadjuvant treatment (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

Stage II Esophageal Cancer, Stage III Esophageal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (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

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

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

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Time Frame

3 years

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

Title

Comparison of pathological diagnosis between specimens of endoscopic biopsy and surgically resected in esophageal cancer

Description

In the group of neoadjuvant radiochemotherapy plus surgery, we will compare the pathological diagnosis between specimens of endoscopic biopsy after neoadjuvant treatment and surgically resected.

Time Frame

2 years

Title

Comparison between gross tumor volume (GTV) delineated with ultrasonic endoscopically placed titanium clips and GTV with conventional contouring method in thoracic esophageal cancer

Description

Time Frame

1 year

Title

Description

Time Frame

1 year

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 esophagocardial cancer patients, with locally advanced resectable tumor, clinically identified before treatment as T1-3N+M0 according to UICC(International Union Against Cancer) TNM(primary tumor, regional nodes, metastasis) Classification of Malignant Tumours, 7th ed. Untreated patients who have not received any antitumor therapy Life expectancy >6 months Age: 18-70 years White blood cell count ≥4.0×109/l, ANC(absolute neutrophil count) ≥1.5×109/l, thrombocyte count ≥1011/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 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 Others.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Dong Qian, Doctor

Phone

+862223341405

qiankeyu1984@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qingsong Pang, Doctor

Organizational Affiliation

Tianjin Medical University Cancer Institute and 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

Citations:

PubMed Identifier

35764191

Citation

Qian D, Chen X, Shang X, Wang Y, Tang P, Han D, Jiang H, Chen C, Zhao G, Zhou D, Cao F, Er P, Zhang W, Li X, Zhang T, Zhang B, Guan Y, Wang J, Yuan Z, Yu Z, Wang P, Pang Q. Definitive chemoradiotherapy versus neoadjuvant chemoradiotherapy followed by surgery in patients with locally advanced esophageal squamous cell carcinoma who achieved clinical complete response when induction chemoradiation finished: A phase II random. Radiother Oncol. 2022 Sep;174:1-7. doi: 10.1016/j.radonc.2022.06.015. Epub 2022 Jun 25.

Results Reference

derived

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A Phase II Trial to Compare Efficacy and Safety of CRT VS Neo-CRT in Patients Who Achieved CCR for Esophageal Cancer

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