Back to resultsStudy of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma (ESO-Shanghai9)
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Fudan Universtiy Shanghai Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chemo-radiation group
Arm Description
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
Outcomes
Primary Outcome Measures
Local control rate
Secondary Outcome Measures
overall survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02916511
Brief Title
Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma
Acronym
ESO-Shanghai9
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chemo-radiation group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin AUC=2, ivgtt, d1, qw*5
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Intervention Description
1.8Gy/d, d1-5/week, 25Fx
Primary Outcome Measure Information:
Title
Local control rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
overall survival
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:
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.
Facility Information:
Facility Name
Fudan Universtiy Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Study of Extensive Clinical Target Volumes in Postoperative Radiotherapy Concurrent With Chemotherapy for Esophageal Squamous Cell Carcinoma
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