NCT04481100

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

July 17, 2020

Last Update Submit

October 13, 2020

Conditions

Esophageal NeoplasmEsophageal DiseasesEsophageal Squamous Cell Carcinoma

Keywords

Esophageal Squamous Cell CarcinomaConcurrent chemoradiotherapyItraconazoleHedgehog pathway

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Treatment-emergent adverse events

    year 0 - year 1

  • Local-regional free survival (LRFS)

    year 0 - year 3

  • Overall survival (OS)

    year 0 - year 3

Study Arms (1)

Experimental Group

EXPERIMENTAL

Itraconazole capsule 100mg twice daily for 6 weeks concurrent with chemoradation.

Drug: itraconazole

Interventions

itraconazoleDRUG

Oral administration of itraconazole twice daily concurrent with chemoradiation

Experimental Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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, 518116, China

RECRUITING

MeSH Terms

Conditions

Esophageal NeoplasmsEsophageal DiseasesEsophageal Squamous Cell Carcinoma

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesGastrointestinal DiseasesCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Central Study Contacts

Shixiu Wu, phD

CONTACT

86-755-66618168wushixiu@medmail.com.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

October 1, 2020

Primary Completion

July 31, 2021

Study Completion

July 31, 2023

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)