NCT02944708

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
384

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2015

Typical duration for phase_3

Geographic Reach
3 countries

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

3 years

First QC Date

October 24, 2016

Last Update Submit

October 26, 2016

Conditions

Nasopharyngeal Carcinoma

Keywords

maintenance chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    From the time point the patients are included in the study, median of 3 years.

Secondary Outcomes (2)

  • 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.

Study Arms (3)

Conventional chemotherapy

ACTIVE COMPARATOR

Patients in this arm will only receive 4-8 cycles of cisplatin-based regimen. TPF ( docetaxel, cisplatin and 5-fluorouracil ), TP (docetaxel and cisplatin), GP (gemcitabine and cisplatin) and PF (cisplatin and 5-fluorouracil) regimens are preferred.

Drug: Conventional chemotherapy

Maintenance chemotherapy 1

EXPERIMENTAL

Patients in this arm will receive 6 cycles of oral fluoropyrimidine monotherapy as maintenance therapy, in addition to 4-8 cycles of cisplatin-based standard chemotherapy.

Drug: Conventional chemotherapyDrug: Maintenance chemotherapy 1

Maintenance chemotherapy 2

EXPERIMENTAL

Patients in this arm will receive oral fluoropyrimidine maintenance therapy until disease progression or intolerable toxicities, after 4-8 cycles of cisplatin-based standard chemotherapy.

Drug: Conventional chemotherapyDrug: Maintenance chemotherapy 2

Interventions

Conventional chemotherapyDRUG
Conventional chemotherapyMaintenance chemotherapy 1Maintenance chemotherapy 2
Maintenance chemotherapy 1DRUG
Maintenance chemotherapy 1
Maintenance chemotherapy 2DRUG
Maintenance chemotherapy 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

RECRUITING

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

The People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

RECRUITING

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

RECRUITING

Jiangxi Province Tumor Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, 201315, China

RECRUITING

Shanghai Proton and Heavy Ion Center

Shanghai, Shanghai Municipality, 201315, China

RECRUITING

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

National Cancer Centre, Singapore

Singapore, 119082, Singapore

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jiade J Lu, MD

    Shanghai Proton and Heavy Ion Center,Shanghai, SPHIC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Kong, MD

CONTACT

lin.kong@sphic.org.cn

Jiyi Hu, MD

CONTACT

jiyi.hu@sphic.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant doctor, chair of head and neck cancer

Study Record Dates

First Submitted

October 24, 2016

First Posted

October 26, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

SG(1)TW(1)CN(12)