NCT03306121

Brief Summary

To see the effect of induction chemotherapy（TPF） followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy (PF) in treating patients with high risk nasopharyngeal carcinoma (NPC).

Trial Health

75
On Track

Trial Health Score

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

Enrollment
322

participants targeted

Target at P50-P75 for phase_3

Timeline
8mo left

Started Nov 2017

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress93%
Nov 2017Dec 2026

First Submitted

Initial submission to the registry

October 1, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

November 13, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

6.1 years

First QC Date

October 1, 2017

Last Update Submit

May 19, 2023

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma;Induction chemotherapy

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival(PFS)

    Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

    3 years

Secondary Outcomes (5)

  • Overall survival(OS)

    3 years

  • Locoregional failure-free survival(LRRFS)

    3 years

  • Distant metastasis-free survival(DMFS)

    3 years

  • Overall response rate

    16 weeks after completion of IMRT

  • Incidence of acute and late toxicity

    3 years

Study Arms (2)

TPF+CCRT

EXPERIMENTAL

Patients receive induction chemotherapy with paclitaxel liposome (135mg/m2 on day 1) ,cisplatin (25mg/m2 on day 1-3) and 5-fluorouracil (750mg/m2 civ 120h) every three weeks for three cycles before radiotherapy, then followed by concurrent IMRT and cisplatin (100mg/m2) concurrent every three weeks during radiotherapy (D1,D22,D43 of RT) .

Drug: TPF+CCRT

CCRT+ PF

ACTIVE COMPARATOR

Patients receive concurrent IMRT and cisplatin (100mg/m2) concurrent every three weeks during radiotherapy (D1,D22,D43 of RT) , then followed by three cycles of adjuvant chemotherapy with cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every four weeks for three cycles four weeks after radiotherapy.

Drug: CCRT+ PF

Interventions

TPF+CCRTDRUG

Patients receive paclitaxel liposome (135mg/m2 on day 1) , cisplatin (25mg/m2 on day 1-3) and 5-fluorouracil (750mg/m2 civ 120h) every three weeks for three cycles of induction chemotherapy before radiotherapy. Patients receive IMRT and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy (D1,D22,D43 of RT)

Also known as: TPF induction chemotherapy
TPF+CCRT
CCRT+ PFDRUG

Patients receive cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every four weeks for three cycles 4 weeks after radiotherapy. Patients receive IMRT and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy (D1,D22,D43 of RT)

Also known as: Adjuvant PF
CCRT+ PF

Eligibility Criteria

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

You may qualify if:

  • Patients with newly histologically confirmed non-keratinizing carcinoma (according to World Health Organization (WHO) histologically type).
  • Original clinical staged as anyT N2-3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）and plasma EBVDNA≥1500copies/ml
  • No evidence of distant metastasis (M0).
  • Age 18-65 years old.
  • ECOG Performance status less or equal to 1
  • Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL.
  • Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) \<1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
  • Adequate renal function: creatinine clearance ≥60 ml/min.
  • Patients must be informed of the investigational nature of this study and give written informed consent.

You may not qualify if:

  • WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
  • Age \<18 or \>65years.
  • Treatment with palliative intent.
  • Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation.
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  • Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
  • Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), and emotional disturbance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Universitty Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (6)

  • Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. doi: 10.1200/JCO.1998.16.4.1310.

    PMID: 9552031RESULT

  • Lee AW, Tung SY, Ngan RK, Chappell R, Chua DT, Lu TX, Siu L, Tan T, Chan LK, Ng WT, Leung TW, Fu YT, Au GK, Zhao C, O'Sullivan B, Tan EH, Lau WH. Factors contributing to the efficacy of concurrent-adjuvant chemotherapy for locoregionally advanced nasopharyngeal carcinoma: combined analyses of NPC-9901 and NPC-9902 Trials. Eur J Cancer. 2011 Mar;47(5):656-66. doi: 10.1016/j.ejca.2010.10.026. Epub 2010 Nov 26.

    PMID: 21112774RESULT

  • Blanchard P, Lee A, Marguet S, Leclercq J, Ng WT, Ma J, Chan AT, Huang PY, Benhamou E, Zhu G, Chua DT, Chen Y, Mai HQ, Kwong DL, Cheah SL, Moon J, Tung Y, Chi KH, Fountzilas G, Zhang L, Hui EP, Lu TX, Bourhis J, Pignon JP; MAC-NPC Collaborative Group. Chemotherapy and radiotherapy in nasopharyngeal carcinoma: an update of the MAC-NPC meta-analysis. Lancet Oncol. 2015 Jun;16(6):645-55. doi: 10.1016/S1470-2045(15)70126-9. Epub 2015 May 6.

    PMID: 25957714RESULT

  • Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. doi: 10.1016/S1470-2045(16)30410-7. Epub 2016 Sep 27.

    PMID: 27686945RESULT

  • Chen C, Wang FH, An X, Luo HY, Wang ZQ, Liang Y, Zhang L, Li YH. Triplet combination with paclitaxel, cisplatin and 5-FU is effective in metastatic and/or recurrent nasopharyngeal carcinoma. Cancer Chemother Pharmacol. 2013 Feb;71(2):371-8. doi: 10.1007/s00280-012-2020-x. Epub 2012 Nov 10.

    PMID: 23143190RESULT

  • Guo SS, Li XY, Liu LT, Jia GD, Liu SL, Sun XS, Luo DH, Yang JH, Xie SY, Li YF, Lv X, Xiang YQ, Xia WX, Sun R, Liu Q, Li JB, Wang P, Yang Q, Wang L, Wen DX, Jin J, Lin JY, Mo HY, Guo L, Zhao C, Guo X, Chen QY, Tang LQ, Mai HQ. Induction vs Adjuvant Chemoradiotherapy in Patients With High-Risk N2 to N3 Nasopharyngeal Carcinoma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2025 Aug 1;11(8):864-873. doi: 10.1001/jamaoncol.2025.1597.

    PMID: 40531520DERIVED

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

  • Hai-Qiang Mai, MD,PhD

    Sun Yat-sen Universitty Cancer Center

    STUDY CHAIR

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
Professor

Study Record Dates

First Submitted

October 1, 2017

First Posted

October 10, 2017

Study Start

November 13, 2017

Primary Completion

December 31, 2023

Study Completion (Estimated)

December 31, 2026

Last Updated

May 22, 2023

Record last verified: 2023-05

Locations

CN(1)