Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
adjuvant treatment
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, adjuvant chemotherapy, adjuvant chemoradiotherapy, surgery
Eligibility Criteria
Inclusion Criteria:
- Participants volunteer to participate the study and signed the informed consent.
- Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
- No antineoplastic treatments before operation.
- According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
- WHO PS score: 0-1;
- Age and gender: 18-75 years old, male and female unlimited;
- Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.
Exclusion Criteria:
- The surgical approach is left thoracic approach;
- Patients with severe postoperative complications who cannot receive adjuvant therapy;
- Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer.
- Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
- Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency;
- Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
- Known or suspected allergy to chemotherapeutic drugs.
Sites / Locations
- Fujian Medical University Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Chemotherapy
Chemoradiotherapy
Surgery alone
Arm Description
Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
Surgery alone, no adjuvant treatment.
Outcomes
Primary Outcome Measures
Overall Survival
overall survival rate of each arms
Overall Survival
overall survival rate of each arms
Secondary Outcome Measures
Disease Free Survival
Disease free survival rate of each arms
Disease Free Survival
Disease free survival rate of each arms
Adverse Events
Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE)
Scores of Quality of Life
Assess the quality of life based on EORTC QLQ-C30 and OES18
Full Information
NCT ID
NCT04009265
First Posted
July 1, 2019
Last Updated
November 10, 2021
Sponsor
Fujian Medical University Union Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04009265
Brief Title
Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma
Official Title
Multicenter Prospective Randomized Controlled Study of Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone in the Treatment of pN1-2 (pT1b-3N1-2M0) Thoracic Esophageal Squamous Cell Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Medical University Union 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
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.
Detailed Description
A multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (OS) and disease-free survival (DFS) of patients with pN1-2 (pT1b-3N1-2M0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, adjuvant chemotherapy, adjuvant chemoradiotherapy, surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
819 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Chemotherapy
Arm Type
Experimental
Arm Description
Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
Arm Title
Chemoradiotherapy
Arm Type
Experimental
Arm Description
5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
Arm Title
Surgery alone
Arm Type
No Intervention
Arm Description
Surgery alone, no adjuvant treatment.
Intervention Type
Combination Product
Intervention Name(s)
adjuvant treatment
Intervention Description
adjuvant treatments include chemotherapy or chemoradiotherapy
Primary Outcome Measure Information:
Title
Overall Survival
Description
overall survival rate of each arms
Time Frame
3-year overall survival
Title
Overall Survival
Description
overall survival rate of each arms
Time Frame
5-year overall survival
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
Disease free survival rate of each arms
Time Frame
3-year disease free survival
Title
Disease Free Survival
Description
Disease free survival rate of each arms
Time Frame
5-year disease free survival
Title
Adverse Events
Description
Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE)
Time Frame
1 year
Title
Scores of Quality of Life
Description
Assess the quality of life based on EORTC QLQ-C30 and OES18
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants volunteer to participate the study and signed the informed consent.
Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
No antineoplastic treatments before operation.
According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
WHO PS score: 0-1;
Age and gender: 18-75 years old, male and female unlimited;
Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.
Exclusion Criteria:
The surgical approach is left thoracic approach;
Patients with severe postoperative complications who cannot receive adjuvant therapy;
Received other anti-tumor treatment before enrollment; At the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer.
Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
Patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; Severe hepatic and renal insufficiency;
Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
Known or suspected allergy to chemotherapeutic drugs.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Zheng, MD
Phone
+8659186218408
Ext
8408
Email
lacustrian@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun Chen, MD
Organizational Affiliation
Fujian Medical University Union Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Zheng, MD
Phone
+8659186218408
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma
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