NCT02143388

Brief Summary

This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

March 31, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 21, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2018

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

4.3 years

First QC Date

May 7, 2014

Last Update Submit

August 30, 2022

Conditions

Local Advanced High Risk Nasopharyngeal Carcinoma

Keywords

Local advancedhigh risknasopharyngeal carcinoma

Outcome Measures

Primary Outcomes (1)

  • Failure free survival

    Defined as the time from date of recruitment to documented relapse or death from any cause.

    3-year

Secondary Outcomes (1)

  • Acute Toxicity

    18 months

Other Outcomes (4)

  • Locoregional relapse free survival

    3-year

  • Distance metastasis free survival

    3-year

  • Overall survival rate

    3-year

  • +1 more other outcomes

Study Arms (2)

Concurrent chemoradiation + adjuvant chemotherapy

EXPERIMENTAL

IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy

Concurrent chemoradiation

ACTIVE COMPARATOR

IMRT combine with cisplatin concurrent chemotherapy

Drug: IMRT combine with cisplatin concurrent chemotherapy

Interventions

IMRT combine with cisplatin concurrent chemotherapyDRUG

Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.

Concurrent chemoradiation
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapyDRUG

Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.

Concurrent chemoradiation + adjuvant chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
  • Clinical stage III\~IVb(UICC 7th)
  • Meet at least one factor below :1 primary tumor SUVmax\>10 in 18F-FDG PET/CT;2 primary tumor volume\>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter\>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA\>2×10E4 copy/l
  • Range from 18～70 years old
  • WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
  • ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN
  • OSerum creatinine \< 1.5×ULN

You may not qualify if:

  • Central nervous system metastases
  • Suitable for local treatment
  • Uncontrolled seizure disorder or other serious neurologic disease
  • Clinically significant cardiac or respiratory disease
  • Drug or alcohol addition
  • Do not have full capacity for civil acts
  • Severe complication, active infection
  • Concurrent immunotherapy or hormone therapy for other diseases
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (2)

  • Liu Y, Yan W, Chen Y, Miao J, Zhang H, Wang J, Zhang Y, Huang X, Wang K, Qu Y, Chen X, Zhang J, Luo J, Li YX, Zhao C, Ma J, Wu R, Yi J. Treatment response-adapted risk index model for survival prediction and adjuvant chemotherapy selection in nonmetastatic nasopharyngeal carcinoma. NPJ Digit Med. 2025 Sep 1;8(1):564. doi: 10.1038/s41746-025-01918-2.

    PMID: 40890288DERIVED

  • Miao J, Wang L, Tan SH, Li JG, Yi J, Ong EHW, Tan LLY, Zhang Y, Gong X, Chen Q, Xiang YQ, Chen MY, Guo Y, Lv X, Xia WX, Tang L, Deng X, Guo X, Han F, Mai HQ, Chua MLK, Zhao C. Adjuvant Capecitabine Following Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2022 Oct 13;8(12):1776-85. doi: 10.1001/jamaoncol.2022.4656. Online ahead of print.

    PMID: 36227615DERIVED

Related Links

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

  • zhao chong, M.D

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 21, 2014

Study Start

March 31, 2014

Primary Completion

July 27, 2018

Study Completion

August 5, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Locations

CN(1)