NCT01540136

Brief Summary

This is a Phase III trial to study the effectiveness of nedaplatin versus cisplatin with IMRT chemoradiotherapy in treating patients with locoregionally advanced nasopharyngeal carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
402

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Typical duration 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

February 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

March 1, 2013

Enrollment Period

2.2 years

First QC Date

February 22, 2012

Last Update Submit

October 27, 2016

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Progress-free survival

    Progress-free survival is calculated from the date of randomization to the date of the first progress at any site.

    2 years

Secondary Outcomes (8)

  • Determine the toxic effects, both quantitatively and qualitatively, and quality of life (QoL) of these regimens in these patients.

    4 weeks

  • Complete Response (CR)

    after the completion of the chemoradiotherapy treatment (up to 9 weeks)

  • Overall Survival(OS)

    2 years

  • Locoregional Relapse-Free Survival(LRRFS)

    2 years

  • Distant Metastasis-Free Survival (DMFS)

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Nedaplatin

EXPERIMENTAL

Nedplatin combine with IMRT

Drug: Nedaplatin

Cisplatin

ACTIVE COMPARATOR

Cisplatin combine with IMRT

Drug: Cisplatin

Interventions

NedaplatinDRUG

Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

Also known as: NDP
Nedaplatin
CisplatinDRUG

Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT

Also known as: DDP
Cisplatin

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 nasopharyngeal carcinoma, including WHO II or III
  • Original clinical staged as T1-4N1-3 or T3-4N0（according to the 7th AJCC edition）
  • No evidence of distant metastasis (M0)
  • Male and no pregnant female
  • Age between 18-65
  • WBC ≥ 4,000/mm3 and PLT ≥ 100,000/mm3
  • With normal liver function test (ALT、AST ≤ 2.5×ULN)
  • With normal renal function test (Creatinine ≤ 1.5×ULN)
  • Satisfactory performance status: Karnofsky scale (KPS)\> 70
  • Without radiotherapy or chemotherapy
  • Patients must give signed informed consent

You may not qualify if:

  • Patients have evidence of relapse or distant metastasis
  • The presence of uncontrolled life-threatening illness
  • Receiving other ways of anti-cancer therapy
  • Receiving radiotherapy or chemotherapy
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (8)

  • Zheng J, Wang G, Yang GY, Wang D, Luo X, Chen C, Zhang Z, Li Q, Xu W, Li Z, Wang D. Induction chemotherapy with nedaplatin with 5-FU followed by intensity-modulated radiotherapy concurrent with chemotherapy for locoregionally advanced nasopharyngeal carcinoma. Jpn J Clin Oncol. 2010 May;40(5):425-31. doi: 10.1093/jjco/hyp183. Epub 2010 Jan 19.

    PMID: 20085903BACKGROUND

  • Fuwa N, Kodaira T, Tachibana H, Nakamura T, Daimon T. Dose escalation study of nedaplatin with 5-fluorouracil in combination with alternating radiotherapy in patients with head and neck cancer. Jpn J Clin Oncol. 2007 Mar;37(3):161-7. doi: 10.1093/jjco/hyl138. Epub 2007 Mar 1.

    PMID: 17332057BACKGROUND

  • Tanaka T, Yukawa K, Umesaki N. Radiation reduces carboplatin sensitivity and enhances nedaplatin sensitivity in cervical squamous cell carcinoma in vitro. Eur J Gynaecol Oncol. 2007;28(5):352-5.

    PMID: 17966212BACKGROUND

  • Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. doi: 10.1093/jnci/djr432. Epub 2011 Nov 4.

    PMID: 22056739BACKGROUND

  • Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. doi: 10.1200/JCO.2002.08.149.

    PMID: 11956263BACKGROUND

  • Ma J, Mai HQ, Hong MH, Min HQ, Mao ZD, Cui NJ, Lu TX, Mo HY. Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma. J Clin Oncol. 2001 Mar 1;19(5):1350-7. doi: 10.1200/JCO.2001.19.5.1350.

    PMID: 11230478BACKGROUND

  • Tang QN, Liu LT, Qi B, Guo SS, Luo DH, Sun R, Sun XS, Chen DP, Guo L, Mo HY, Wang P, Liu SL, Liang YJ, Li XY, Yang ZC, Chen QY, Mai HQ, Tang LQ. Effect of Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin on the Long-term Outcomes of Survival and Toxic Effects Among Patients With Stage II to IVB Nasopharyngeal Carcinoma: A 5-Year Follow-up Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Dec 1;4(12):e2138470. doi: 10.1001/jamanetworkopen.2021.38470.

    PMID: 34928359DERIVED

  • Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. doi: 10.1016/S1470-2045(18)30104-9. Epub 2018 Feb 28.

    PMID: 29501366DERIVED

Related Links

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

nedaplatinCisplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • HaiQiang Mai, MD,Ph.D

    Cancer center

    PRINCIPAL INVESTIGATOR

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
Deputy Director of the Department of Nasopharyngeal Carcinoma

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 28, 2012

Study Start

February 1, 2012

Primary Completion

May 1, 2014

Study Completion

July 1, 2016

Last Updated

October 28, 2016

Record last verified: 2013-03

Locations

CN(1)