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出境医 / 临床实验 / Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma

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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Combination Product: adjuvant treatment Phase 3

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 819 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 23, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2027
Arms and Interventions
Arm Intervention/treatment
Experimental: Chemotherapy
Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
 Combination Product: adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
Experimental: Chemoradiotherapy
5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
 Combination Product: adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
No Intervention: Surgery alone
Surgery alone, no adjuvant treatment.
Outcome Measures
Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3-year overall survival ]
    overall survival rate of each arms

  2. Overall Survival [ Time Frame: 5-year overall survival ]
    overall survival rate of each arms


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: 3-year disease free survival ]
    Disease free survival rate of each arms

  2. Disease Free Survival [ Time Frame: 5-year disease free survival ]
    Disease free survival rate of each arms

  3. Adverse Events [ Time Frame: 1 year ]
    Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE)

  4. Scores of Quality of Life [ Time Frame: 5 years ]
    Assess the quality of life based on EORTC QLQ-C30 and OES18


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants volunteer to participate the study and signed the informed consent.
  2. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
  3. No antineoplastic treatments before operation.
  4. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
  5. WHO PS score: 0-1;
  6. Age and gender: 18-75 years old, male and female unlimited;
  7. Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.

Exclusion Criteria:

  1. The surgical approach is left thoracic approach;
  2. Patients with severe postoperative complications who cannot receive adjuvant therapy;
  3. 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.
  4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
  5. 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;
  6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
  7. Known or suspected allergy to chemotherapeutic drugs.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Bin Zheng, MD +8659186218408 ext 8408 lacustrian@163.com

Locations
Layout table for location information
China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350001
Contact: Bin Zheng, MD    +8659186218408      
Sponsors and Collaborators
Fujian Medical University Union Hospital
Investigators
Layout table for investigator information
Study Director: Chun Chen, MD Fujian Medical University Union Hospital
Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date September 6, 2019
Actual Study Start Date  ICMJE August 23, 2019
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Overall Survival [ Time Frame: 3-year overall survival ]
    overall survival rate of each arms
  • Overall Survival [ Time Frame: 5-year overall survival ]
    overall survival rate of each arms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Disease Free Survival [ Time Frame: 3-year disease free survival ]
    Disease free survival rate of each arms
  • Disease Free Survival [ Time Frame: 5-year disease free survival ]
    Disease free survival rate of each arms
  • Adverse Events [ Time Frame: 1 year ]
    Number and degree of Adverse Events based on Common Toxicity Criteria for Adverse Effects(CTCAE)
  • Scores of Quality of Life [ Time Frame: 5 years ]
    Assess the quality of life based on EORTC QLQ-C30 and OES18
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Compare Adjuvant Chemotherapy, Chemoradiotherapy and Surgery Alone for pN1-2(pT1b-3N1-2M0) Esophageal Carcinoma
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE Combination Product: adjuvant treatment
adjuvant treatments include chemotherapy or chemoradiotherapy
Study Arms  ICMJE
  • Experimental: Chemotherapy
    Docetaxel 75mg/m2, 3w, 2cycles. DDP 75mg/m2, 3wl, 2cycles.
    Intervention: Combination Product: adjuvant treatment
  • Experimental: Chemoradiotherapy
    5040cGy, 180cGy/d, 28F Concurrent Docetaxel 60mg/m2, 3w, 2cycles DDP 60mg/m2, 3w, 2cycles
    Intervention: Combination Product: adjuvant treatment
  • No Intervention: Surgery alone
    Surgery alone, no adjuvant treatment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		819
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2027
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participants volunteer to participate the study and signed the informed consent.
  2. Surgical methods: Radical resection of tumors (R0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma.
  3. No antineoplastic treatments before operation.
  4. According to the 8th edition of AJCC staging, pN1-2 (pT1b-3N1-2M0) stage of esophageal cancer;
  5. WHO PS score: 0-1;
  6. Age and gender: 18-75 years old, male and female unlimited;
  7. Laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements.

Exclusion Criteria:

  1. The surgical approach is left thoracic approach;
  2. Patients with severe postoperative complications who cannot receive adjuvant therapy;
  3. 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.
  4. Abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment;
  5. 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;
  6. Patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response;
  7. Known or suspected allergy to chemotherapeutic drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bin Zheng, MD +8659186218408 ext 8408 lacustrian@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04009265
Other Study ID Numbers  ICMJE ACRTEC UNION
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fujian Medical University Union Hospital
Study Sponsor  ICMJE Fujian Medical University Union Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chun Chen, MD Fujian Medical University Union Hospital
PRS Account Fujian Medical University Union Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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