- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02916511
Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma (ESO-Shanghai9)
December 21, 2023 updated by: Kuai Le Zhao, MD, Fudan University
The purpose of this study is to evaluate safety and 2-year local control rate for extensive clinical target volumes in postoperative radiotherapy concurrent with chemotherapy for esophageal squamous cell carcinoma.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Fudan Universtiy Shanghai Cancer Center
-
-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Joined the study voluntarily and signed informed consent form;
- Age 18-75;
- ECOG 0-2;
- Esophageal squamous cell carcinoma, radical surgery ≤ 3 months, R0 resection;
- The operative incision healed well;
- T3-4N0M0, T1-4N1-3M0 (according to AJCC2009);
- No radiotherapy, chemotherapy or other treatments pre (post) surgery;
- PS ECOG 0-2;
- Life expectancy of more than 3 months;
- Hemoglobin (Hb) ≥ 9 g/dL • WBC ≥ 3 x 109/L, Neutrophils (ANC ) ≥ 1.5 x 109/L • platelet count (Pt) ≥ 100 x 109/L • Hepatic function: ALAT and ASAT < 2.5 x ULN, TBIL< 1.5 x ULN • Renal function: creatinine < 1.5 x ULN
- No immuno-deficiency;
- Use of an effective contraceptive for adults to prevent pregnancy.
Exclusion Criteria:
- Complete esophageal obstruction after surgery, Esophageal perforation, Haematemesis;
- Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years;
- Participation in other interventional clinical trials within 30 days;
- Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives;
- Drug addiction, Alcoholism or AIDS;
- Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior;
- Unsuitable to be enrolled in the trial in the opinion of the investigators.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemo-radiation group
A total dose of 45Gy will be delivered in 25 fractions at 1.8Gy/fraction, 5 fractions per week in 5 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and celiac nodes. Paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1; Carboplatin AUC=2, ivgtt, d1; qw*5 |
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
carboplatin AUC=2, ivgtt, d1, qw*5
1.8Gy/d, d1-5/week, 25Fx
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Local control rate
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 1, 2016
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2023
Study Registration Dates
First Submitted
September 26, 2016
First Submitted That Met QC Criteria
September 26, 2016
First Posted (Estimated)
September 27, 2016
Study Record Updates
Last Update Posted (Actual)
December 22, 2023
Last Update Submitted That Met QC Criteria
December 21, 2023
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
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- ESO-Shanghai9
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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