Adjuvant Radiotherapy for Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin
Adjuvant Radiotherapy for T3N0M0 Esophageal Squamous Cell Carcinoma With Positive Circumstantial Resection Margin(a Randomized Controlled Trial)
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to determine the efficacy of adjuvant radiotherapy for esophageal squamous cell carcinoma with positive circumstantial resection margin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2017
Longer than P75 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
September 6, 2017
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedOctober 19, 2017
October 1, 2017
2 years
September 4, 2017
October 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-free survival time
including survival time from randomization to locoregional recurrence and to distal metastasis
up to 3 years
Secondary Outcomes (1)
overall survival time
up to 3 years
Study Arms (2)
surgery plus radiation
EXPERIMENTALadjuvant radiotherapy is developed in this arm
surgery alone
NO INTERVENTIONNo adjuvant radiotherapy,that is surgery alone is developed in this arm
Interventions
A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks. The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes.
Eligibility Criteria
You may qualify if:
- Patients with esophageal cancer who received R0 operations in Fudan University Shanghai Cancer Center and postoperative pathology: squamous cell cancer,positive Circumferential Resection Margin(CRM)+
- KPS≥70 before radiotherapy;
- Did not receive neoadjuvant or adjuvant treatment;
- No clear recurrent or metastatic lesions before radiotherapy;
- Intensity modulated radiation therapy(IMRT) is accepted;
- Regular follow-up.
You may not qualify if:
- Exploratory thoracotomy or palliative surgery;
- No clear recurrent or metastatic sites;
- Recurrence or metastasis is not certain;
- death of no definite cause.
- Irregular follow-up;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiaqing Xiang, MD
professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Department of Thoracic Surgery, Fudan University Shanghai Cancer Center
Study Record Dates
First Submitted
September 4, 2017
First Posted
September 6, 2017
Study Start
December 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2024
Last Updated
October 19, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share