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A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer

Primary Purpose

Stage II Esophageal Cancer, Stage III Esophageal Cancer

Status

Not yet recruiting

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Definitive Radiochemotherapy

Neoadjuvant Radiochemotherapy

About this trial

This is an interventional treatment trial for Stage II Esophageal Cancer focused on measuring Neoadjuvant Chemoradiation, Definitive Chemoradiation, Clinical complete response

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, 8th 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 who suffered from hemorrhage or complicated hemorrhage;
Other uncontrollable patients who are not suitable for surgery;
Female patients in pregnancy or lactation;
Patients who agree without acknowledgement due to psychic, family or social factors;
Patients who suffered from peripheral neuropathy, with CTC grade ≥2;
Patients who ever suffered from other types of malignant tumor other than esophagus cancer;
Patients who have diabetes history over 10 yrs and blood glucose level is not satisfyingly controlled;
Patients who suffer from serious malfunction of heart, lung, liver or kidney, hemotopathy, immune system disease or cachexia and therefore can't tolerate chemotherapy or surgery;
Others.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Definitive Radiochemotherapy

Neoadjuvant Radiochemotherapy

Arm Description

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

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.

Full Information

NCT ID

NCT03708042

First Posted

October 12, 2018

Last Updated

October 15, 2018

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University, Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT03708042

Brief Title

A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer

Official Title

A Phase Ⅲ Trial to Compare Efficacy and Safety of Definitive Chemoradiation VS Neoadjuvant Chemoradiation Plus Surgery in Patients Who Achieved Clinical Complete Response After Neoadjuvant Treatment for Locally Advanced Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Not yet recruiting

Study Start Date

December 1, 2018 (Anticipated)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Sun Yat-sen University, Peking University Cancer Hospital & Institute

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

Neoadjuvant chemoradiotherapy(Neo-CRT) plus surgery has been regarded as a standard of care for patients with resectable locally advanced esophageal 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 Ⅲ multicenter 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 resectable locally advanced 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 major 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

Keywords

Neoadjuvant Chemoradiation, Definitive Chemoradiation, Clinical complete response

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Definitive Radiochemotherapy

Arm Type

Experimental

Arm Description

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

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

Combination Product

Intervention Name(s)

Definitive Radiochemotherapy

Intervention Description

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

Intervention Type

Combination Product

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

3 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 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, 8th 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 who suffered from hemorrhage or complicated hemorrhage; Other uncontrollable patients who are not suitable for surgery; Female patients in pregnancy or lactation; Patients who agree without acknowledgement due to psychic, family or social factors; Patients who suffered from peripheral neuropathy, with CTC grade ≥2; Patients who ever suffered from other types of malignant tumor other than esophagus cancer; Patients who have diabetes history over 10 yrs and blood glucose level is not satisfyingly controlled; Patients who suffer from serious malfunction of heart, lung, liver or kidney, hemotopathy, immune system disease or cachexia and therefore can't tolerate chemotherapy or surgery; Others.

Central Contact Person:

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

Dong Qian, PHD & MD

Phone

+862223341405

qiankeyu1984@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ping Wang, PHD & MD

Organizational Affiliation

Department of Radiation Oncology, Tianjin Medical University Cancer Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study to Compare Efficacy and Safety of DRT VS CRT Plus Surgery in Patients Who Achieved CCR for Esophageal Cancer

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