Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

NCT03904225 | Unknown Phase 2

• 1 other identifier: NPC 2018 Tegio
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasopharyngeal Carcinoma

Keywords

adjuvant chemotherapy; Tegio

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

tegio

EXPERIMENTAL

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

Drug: Tegafur-Gimeracil-Oteracil

control

NO INTERVENTION

patients was oberved

Interventions

Tegafur-Gimeracil-Oteracil DRUG

oral administration for 12 months

tegio

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

tegafur-gimeracil-oteracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

feng Jiang, MD

CONTACT

0086-571-88128202; jiangfeng@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: April 5, 2019
• Study Start: December 14, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-04

Locations

CN (1)