Brief Title
Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis
Official Title
Efficacy and Safety Evaluation of Tegio Consolidation Therapy in the Treatment of Nasopharyngeal Carcinoma With High Risk of Metastasis: a Phase II Study
Brief Summary
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.
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
distant metastsis-free survival (DMFS)
Condition
Nasopharyngeal Carcinoma
Intervention
Tegafur-Gimeracil-Oteracil
Study Arms / Comparison Groups
tegio
Description: Tegio 60mg bid d1-28 q6wks was administered until disease progression, unacceptable toxicity,or over 12monthes within 3monthes after curative chemoradiation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
220
Start Date
December 14, 2018
Completion Date
December 2022
Primary Completion Date
December 2022
Eligibility Criteria
Inclusion Criteria:
1. Age 18-70 ys
2. Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 -2
3. Tumor staged as 8th American Joint Committee on Cance (AJCC) T3-4N2M0 or T1-4N3M0 with
histologically confirmed
4. Within 12weeks after completion of the curative radiotherapy treatment
5. disease was controlled after radiotherapy
6. 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)
7. Patients must be informed and written informed consent was finished.
Exclusion Criteria:
1. allergic to Tegio.
2. Illness may interfere with oral medication, including dysphagia, chronic diarrhea, or
ileus
3. Prior malignancy except treated basal cell or in situ cervical cancer.
4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and
emphasize effective contraception during the treatment period).
5. 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.
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
, 0086-571-88128202, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03904225
Organization ID
NPC 2018 Tegio
Responsible Party
Sponsor
Study Sponsor
Zhejiang Cancer Hospital
Study Sponsor
, ,
Verification Date
April 2019