Docetaxel-polymeric Micelles(PM) and Oxaliplatin for Esophageal Carcinoma (NCT03585673) | Clinical Trial Compass
UnknownPhase 2
Docetaxel-polymeric Micelles(PM) and Oxaliplatin for Esophageal Carcinoma
South Korea38 participantsStarted 2018-06-01
Plain-language summary
Esophageal or esophageal-gastric junction squamous cell cancer has dismal prognosis. And still no promising chemotherapeutic drugs is existed. In this study, The investigators wanted to look at the effects and safety of first line docetaxel-PM and oxaliplatin weekly administration chemotherapy for the participants with inoperable or metastatic esophageal squamous cell carcinoma.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. A patient whose squamous cell cancer of the esophagus or esophago-gastric junction has been confirmed by biopsy or cytology.
✓. A patient who is not subject to local treatment such as surgical excision or concurrent definitive chemoradiotherapy.
✓. Metastatic or relapsed esophageal cancer patients who planned first line palliative treatment.
✓. Patients' age over 18
✓. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2
✓. Patient has measurable lesions with RECIST v1.1
✓. Patients with appropriate organ functions, such as the following, within seven days prior to the start of a clinical trial
✓. Patients with at least three months of an expected life.
Exclusion criteria
✕. In the case that the following treatment has been received in the past for the local stage treatment more than 6 months from the end of the treatment, enrolment is allowed.
✕. Patients with a history of administration of docetaxel, paclitaxel, or oxaliplatin at any time in the past.
✕. Patients who have been treated for other active cancers other than esophageal cancer less than five years (but cured kin basal cell cancer or cured cervical carcinoma in situ are excluded).
. The clinically confirmed esophagus obstruction, gastrointestinal bleeding, or perforation (except if the symptoms are sufficiently controlled through proper procedures such as stents).
✕. Patients with significant, uncontrolled cardiovascular disease, infection, or infectious fever.
✕. Patients with uncontrolled brain metastasis.
✕. In the case of major surgery within the first two weeks of clinical trial treatment, the patient must recover sufficiently from the effects of this surgery.
✕. Patients with pregnancy, breast feeding, or future plans.