Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

University of Chinese Academy Sciences

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Tegafur-Gimeracil-Oteracil

Study type: Interventional

Funder types: Other

Identifiers

NCT03904225

NPC 2018 Tegio

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

tegio

Experimental group

Description:

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

Treatment:

Drug: Tegafur-Gimeracil-Oteracil

control

No Intervention group

Description:

patients was oberved