Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03904225
• Other study ID #: NPC 2018 Tegio
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2018
• Est. completion date: December 2022

Study information

• Verified date: April 2021
• Source: Zhejiang Cancer Hospital
• Contact: feng Jiang, MD
• Phone: 0086-571-88128202
• Email: jiangfeng[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Tegafur-Gimeracil-Oteracil
oral administration for 12 months

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	distant metastsis-free survival (DMFS)	distant metastsis-free survival	From date of randomization until the date of first documented distant disease failure, assessed up to 36 months