Back to resultsCCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
Primary Purpose
Esophageal Neoplasm, Esophageal Diseases, Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
itraconazole
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Neoplasm focused on measuring Esophageal Squamous Cell Carcinoma, Concurrent chemoradiotherapy, Itraconazole, Hedgehog pathway
Eligibility Criteria
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,Ⅱ-Ⅳa(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.
Sites / Locations
- National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Group
Arm Description
Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1
Secondary Outcome Measures
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.
Local-regional free survival (LRFS)
LRFS was calculated from the date of treatment initiation to the date of documented failure.
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.
Full Information
NCT ID
NCT04481100
First Posted
July 17, 2020
Last Updated
October 13, 2020
Sponsor
Hangzhou Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04481100
Brief Title
CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
Official Title
Phase II Study of Concurrent Chemoradiotherapy With Itraconazole in Treating Patients With Locally Advanced Esophageal Squamous Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
Detailed Description
Esophageal cancer is one of the most lethal malignancies. Esophageal squamous cell carcinoma (ESCC) is the predominant type in China, accounting for over 90% of all esophageal cancer. Concurrent chemoradiation therapy (CCRT) remains the standard therapy of locally advanced ESCC. However, the outcome remains poor.
The aberrant activation of Hedgehog (HH) signaling is associated with a variety of human malignancies. Previous studies found that the reactivation of HH pathway occurs in 60% of esophageal cancer. Targeting the Hh pathway for cancer therapy was expected to work wonders in Hh-dependent cancers. Itraconazole, an antifungal agent, has been shown to inhibit the Hh and AKT signaling pathways.
The aim of our study is to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with Itraconazole in patients with locally adcvanced esophageal squamous cancer
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Neoplasm, Esophageal Diseases, Esophageal Squamous Cell Carcinoma
Keywords
Esophageal Squamous Cell Carcinoma, Concurrent chemoradiotherapy, Itraconazole, Hedgehog pathway
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.
Intervention Type
Drug
Intervention Name(s)
itraconazole
Intervention Description
Oral administration of itraconazole twice daily concurrent with chemoradiation
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
ORR was evaluated 4-8 weeks after completion of RT and was recorded according to RECIST, version 1.1
Time Frame
4-8 weeks
Secondary Outcome Measure Information:
Title
Treatment-emergent adverse events
Description
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.
Time Frame
year 0 - year 1
Title
Local-regional free survival (LRFS)
Description
LRFS was calculated from the date of treatment initiation to the date of documented failure.
Time Frame
year 0 - year 3
Title
Overall survival (OS)
Description
OS was determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.
Time Frame
year 0 - year 3
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:
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,Ⅱ-Ⅳa(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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shixiu Wu, phD
Phone
86-755-66618168
Email
wushixiu@medmail.com.cn
Facility Information:
Facility Name
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518116
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shixiu Wu, phD
Phone
+8675566618168
Email
wushixiu@medmail.com.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CCRT With Itraconazole in Locally Advanced Squamous Esophageal Cancer
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