Completed
Phase II Study of S-1 in Combination With Radiotherapy in Esophageal Squamous Cell Carcinoma
What is being tested
S-1
+ Radiation therapy
DrugRadiation
Who is being recruted
Carcinoma+12
+ Carcinoma, Squamous Cell
+ Digestive System Diseases
Over 18 Years
+27 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: March 2013
Summary
Principal SponsorFudan University
Last updated: February 15, 2019
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2013
Actual date on which the first participant was enrolled.This trial aims to study the safety, the local control, and the overall survival of S-1 combined with radiotherapy for patients with esophageal squamous cell carcinoma. 105 patients will be recruited into this trial.
Principal SponsorFudan University
Last updated: February 15, 2019
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
105 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
CarcinomaCarcinoma, Squamous CellDigestive System DiseasesDigestive System NeoplasmsEsophageal DiseasesEsophageal NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialNeoplasms, Squamous CellEsophageal Squamous Cell Carcinoma
Criteria
15 inclusion criteria required to participate
Age > 75 or age 18-75 who are intolerant of or reject intravenous chemotherapy
Both genders
Esophageal squamous cell carcinoma confirmed by pathology
Hemoglobin(Hb) >= 9 g/dL
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12 exclusion criteria prevent from participating
After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
Alcoholism or AIDS
Complete esophageal obstruction
Deep esophageal ulcer
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalPatients will receive chemoradiation with S-1.
Interventions:
Drug: S-1 Radiation: Radiation therapy
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center