- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904225
Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis
June 21, 2021 updated by: Zhejiang Cancer Hospital
Efficacy and Safety Evaluation of Tegio Consolidation Therapy in the Treatment of Nasopharyngeal Carcinoma With High Risk of Metastasis: a Phase II Study
oral administration of Tegio capsules for 12 months for NPC patients with high risk of metastasis (AJCC stage T3-4N2M0 or T1-4N3M0) was tested trying to reduce distant metastasis,safety was also evaluated.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In this study, NPC patients (stage T3-4N2M0 or T1-4N3M0) who finished the curative chemoradiation will be randomized to the observation group and treatment group (60 mg bid, p.o.,d1-28,q6wks; continued until disease progression, unacceptable toxicity, or over 1 year).
The primary endpoint is distant failure-free survival (D-FFS), Secondary end points include overall survival (OS), locoregional failure-free survival (LR-FFS), progression-free survival (PFS) and toxic effects,.
All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.
Study Type
Interventional
Enrollment (Anticipated)
220
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-70 ys
- Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 -2
- Tumor staged as 8th American Joint Committee on Cance (AJCC) T3-4N2M0 or T1-4N3M0 with histologically confirmed
- Within 12weeks after completion of the curative radiotherapy treatment
- disease was controlled after radiotherapy
- with adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase < 2.5×ULN) and renal function (creatinine clearance > 50 ml/min)
- Patients must be informed and written informed consent was finished.
Exclusion Criteria:
- allergic to Tegio.
- Illness may interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
- Prior malignancy except treated basal cell or in situ cervical cancer.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- severe comorbidities may bring unacceptable risk or affect the compliance of the trial, including but not limited to unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: tegio
Tegio 60mg bid d1-28 q6wks was administered until disease progression, unacceptable toxicity,or over 12monthes within 3monthes after curative chemoradiation
|
oral administration for 12 months
|
NO_INTERVENTION: control
patients was oberved
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
distant metastsis-free survival (DMFS)
Time Frame: From date of randomization until the date of first documented distant disease failure, assessed up to 36 months
|
distant metastsis-free survival
|
From date of randomization until the date of first documented distant disease failure, assessed up to 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 14, 2018
Primary Completion (ANTICIPATED)
December 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
January 1, 2019
First Submitted That Met QC Criteria
April 3, 2019
First Posted (ACTUAL)
April 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 23, 2021
Last Update Submitted That Met QC Criteria
June 21, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tegafur
Other Study ID Numbers
- NPC 2018 Tegio
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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