- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03600831
Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
January 6, 2024 updated by: Huai'an First People's Hospital
A Randomized Phase Ⅱ/Ⅲ Trial of Postoperative Concurrent Chemoradiotherapy Versus Radiotherapy Alone for Patients With Locoregionally Advanced Esophageal Squamous Cell Carcinoma
The aim of this study is to investigate the effect of postoperative concurrent chemoradiotherapy versus radiotherapy alone for patients with locally advanced esophageal squamous cell carcinoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
434
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: wei-guo zhu, MD
- Phone Number: +8613511555000
- Email: jshazwg@126.com
Study Locations
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Jiangsu
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Huai'an, Jiangsu, China, 223300
- Chinese Peiple's Liberation Army No.82 Hospital
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Huai'an, Jiangsu, China, 223300
- Huai'an second peiple's Hospital
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Huai'an, Jiangsu, China, 223300
- Lianshui County Peoples Hospital
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Xu Yi, Jiangsu, China, 211700
- xuyi peiple's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- biopsy-confirmed esophageal squamous cell carcinoma
- age ≤ 70 years old,
- Karnofsky performance status ≥ 70,
- R0 esophagectomy according to the pathological examination of the resected specimens,
- postoperative stage Ⅱ-Ⅳa according to the AJCC 7th edition of tumor-node-metastasis (TNM) classification for esophageal carcinoma
- Adequate organ functions (1).white blood cell (WBC) ≥3×109⁄L; (2).Absolute neutrophil counts (ANC) ≥1.5×109⁄L; (3).Hemoglobin (Hb) ≥10g⁄dl; (4).Platelet (Plt) ≥100×109⁄L; (5).Total bilirubin <1.5 upper limit of normal (ULN); (6).Aspartate transaminase (AST) ≤2.5 ULN; (7).Alanine aminotransferase (ALT) ≤2.5 ULN; (8).Creatinine ≤1.5 ULN; (9).adequate pulmonary function (FEV1>0.8 L;.
- no previous treatment or severe complications
- Written informed consent
Exclusion Criteria:
- previous treatment with chemotherapy or radiotherapy
- greater than 3 months after surgery
- complete esophageal obstruction after surgery, esophageal perforation;
- other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- pregnant or breast-feeding women;
- patients with any serious concurrent disease, such as severe diabetes, uncontrolled hypertension, serious chronic obstructive pulmonary disease;
- drug addiction, Alcoholism or AIDS;
- uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- with clear chemotherapy drug allergy
- participation in other interventional clinical trials within 30 days;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: concurrent chemoradiotherapy group
All patients in this group will receive concurrent chemoradiotherapy with DP regimen (docetaxel plus cisplatin).
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cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks
radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)
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Active Comparator: radiotherapy group
All patients in this group will receive radiotherapy alone 50Gy (2.0 Gy/fraction, 5 days a week).
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radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival (DFS)
Time Frame: From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
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From the date of randomization to the date of first observation of disease progression, or relapse, or death due to any cause。
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From date of randomization to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
treatment-related toxicities
Time Frame: From the date of randomization until six months after treatment completion
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Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria (NCICTC), version 3.0
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From the date of randomization until six months after treatment completion
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Overall survival (OS)
Time Frame: From date of randomization to death from any cause, assessed up to 3 years
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From the date of randomization until the date of death
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From date of randomization to death from any cause, assessed up to 3 years
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Quality of life(QOL)
Time Frame: 1 year
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Quality of life of patient will be evaluated using EORTC QLQ-C30.
Evaluation of quality of life will be performed every 3 months.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2018
Primary Completion (Actual)
May 30, 2022
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
July 3, 2018
First Submitted That Met QC Criteria
July 16, 2018
First Posted (Actual)
July 26, 2018
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
January 6, 2024
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- huaianzhuweiguo
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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