Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

A Randomized Phase III Trial Evaluating Maintenance Chemotherapy for Metastatic Nasopharyngeal Carcinoma

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02944708

Enrollment

384

Registered

2016-10-26

Start date

2015-10-31

Completion date

2018-10-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Carcinoma

Keywords

maintenance chemotherapy

Brief summary

The purpose of this study is to examine the efficacy of maintenance chemotherapy for the treatment of metastatic nasopharyngeal carcinoma. Participants will be randomized to 3 arms. Arm 1, control group, participants will receive only 4-8 cycles of conventional chemotherapy; arm 2, participants will receive 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3, experiment arm, after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities.

Detailed description

This is a phase 3 randomized clinical trial to determine the efficacy of maintenance chemotherapy for the treatment of metastatic chemotherapy and how it should be delivered. Participants will be randomized to 3 arms. Arm 1 (control group), participants will receive only conventional chemotherapy; arm 2 (experimental group), participants will receive up to 6 cycles of maintenance chemotherapy after conventional chemotherapy; arm 3 (experimental group), after conventional chemotherapy, participants will receive maintenance chemotherapy until disease progression or intolerable toxicities. Participants in all 3 arms will receive similar conventional chemotherapy. Four to eight cycles of conventional chemotherapy with platinum-based regimen is preferred. Maintenance chemotherapy should use one of the regimens: S1 (40mg, twice a day for 14 days, every 3 weeks), capecitabine (1000mg/m\^2, twice a day for 14 days, every 3 weeks) or Tegafur-uracil (100mg/m\^2, q8h, for 14 days, every 3 weeks). The response of treatment will be evaluated according to RECIST criteria. Adverse events will be documented according to CTCAE v4.03.

Interventions

DRUGConventional chemotherapy

DRUGMaintenance chemotherapy 1

DRUGMaintenance chemotherapy 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age ≥ 18 and ≤ 70 years * Histologically confirmed nasopharyngeal carcinoma, WHO (World Health Organization) classification II/III * With distant metastasis * With measurable lesions that can be detected by imaging studies * Achieving PR (partial response) after 4 cycles of conventional chemotherapy * Life expectancy ≥ 6 months * ECOG (Eastern Cooperative Oncology Group): 0-1, no significant active concurrent medical illnesses * Adequate laboratory values within 30 dyas of enrollment to study defined as follows: N \> 2000/mm\^3; PLT (platelet count) \> 100,000/mm\^3; total bilirubin \< 1.5mg/dl; AST (aspartate aminotransferase)/ALT (alanine aminotransferase) \< 1.5 ULN (upper limit of normal); SCr (serum creatinine) \< 1.5mg/dl; CCR (creatinine clearance rate) \> 60ml/min * Willing to accept adequate contraception for women with childbearing potential * Ability to understand character and individual consequences of the clinical trial * Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial

Exclusion criteria

* Received previous treatment for metastatic disease * Pregnant or lactating women * A diagnosis of malignancy other than CIS (carcinoma in situ) of the cervix, BCC (basal cell carcinoma) and SCC (squamous cell carcinoma) of the skin within the past 5 years * Refusal of the patient to participate into the study

Design outcomes

Primary

Measure	Time frame
Progression-free survival	From the time point the patients are included in the study, median of 3 years.

Secondary

Measure	Time frame
Overall survival	From the time point the patients are included in the study, median of 3 years.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	From the time point the patients are included in the study, median of 3 years.

Countries

China, Singapore, Taiwan

Contacts

Primary ContactLin Kong, MD

lin.kong@sphic.org.cn

Backup ContactJiyi Hu, MD

jiyi.hu@sphic.org.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026