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Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tegafur-Gimeracil-Oteracil

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring adjuvant chemotherapy, Tegio

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

tegio

control

Arm Description

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

patients was oberved

Outcomes

Primary Outcome Measures

distant metastsis-free survival (DMFS)

distant metastsis-free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT03904225

First Posted

January 1, 2019

Last Updated

June 21, 2021

Sponsor

Zhejiang Cancer Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03904225

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 14, 2018 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

adjuvant chemotherapy, Tegio

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tegio

Arm Type

Experimental

Arm Description

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

Arm Title

control

Arm Type

No Intervention

Arm Description

patients was oberved

Intervention Type

Drug

Intervention Name(s)

Tegafur-Gimeracil-Oteracil

Intervention Description

oral administration for 12 months

Primary Outcome Measure Information:

Title

distant metastsis-free survival (DMFS)

Description

distant metastsis-free survival

Time Frame

From date of randomization until the date of first documented distant disease failure, assessed up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

feng Jiang, MD

Phone

0086-571-88128202

jiangfeng@zjcc.org.cn

Facility Information:

Facility Name

Zhejiang Cancer Hospital

City

Hangzhou

State/Province

Zhejiang

ZIP/Postal Code

310022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaozhong Chen, MD

Phone

86-571-88122098

cxzfyun@sina.com

First Name & Middle Initial & Last Name & Degree

Xiaozhong Chen, MD

12. IPD Sharing Statement

Learn more about this trial

Tegio Consolidation Therapy for NPC Patients With High Risk of Metastasis

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