Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

NCT ID: NCT03904225

Last Updated: 2021-06-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2022-12-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tegio

Tegio 60mg bid d1-28 q6wks was administered until disease progression, unacceptable toxicity,or over 12monthes within 3monthes after curative chemoradiation

Group Type: EXPERIMENTAL

Tegafur-Gimeracil-Oteracil

Intervention Type: DRUG

oral administration for 12 months

control

patients was oberved

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tegafur-Gimeracil-Oteracil

oral administration for 12 months

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

feng Jiang, MD

Role: CONTACT

jiangfeng@zjcc.org.cn

0086-571-88128202

Facility Contacts

Xiaozhong Chen, MD

Role: primary

cxzfyun@sina.com

86-571-88122098

Other Identifiers

NPC 2018 Tegio

Identifier Type: -

Identifier Source: org_study_id