Esophageal Squamous Cell Carcinoma Clinical Trial
Official title:
Phase II Study of Concurrent Chemoradiotherapy With Itraconazole in Treating Patients With Locally Advanced Esophageal Squamous Cancer
The objective of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer
Status | Recruiting |
Enrollment | 38 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: age:18-75 years, male or femal. Histologically or cytologically confirmed Squamous Cell Carcinoma of the Esophagus, locally advanced, unresectable disease. Clinical staged T3-4N0M0, T1-4N+M0,?-?a(AJCC 8th) Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. ECOG 0-1. Adequate organ function. Patient has given written informed consent. Exclusion Criteria: Unwilling or unable to provide informed consent Known allergy to itraconazole Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. Complete obstruction of the esophagus, or patients who have the potential to develop perforation, or unable to swallow Itraconazole. Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers. Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent. Pregnancy or breast-feeding. Decision of unsuitableness by principal investigator or physician-in-charge. |
Country | Name | City | State |
---|---|---|---|
China | National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Shenzhen | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Hangzhou Cancer Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) | ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1 | 4-8 weeks | |
Secondary | Treatment-emergent adverse events | Incidence of treatment-emergent adverse events would be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0) and EORTC criterion. | year 0 - year 1 | |
Secondary | Local-regional free survival (LRFS) | LRFS was calculated from the date of treatment initiation to the date of documented failure. | year 0 - year 3 | |
Secondary | Overall survival (OS) | OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death. | year 0 - year 3 |
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