NCT02610556

Brief Summary

The investigators aim to evaluate the efficiency and toxicities of concurrent docetaxel and cisplatin with intensity-modulated radiotherapy in high risk locoregionally advanced nasopharyngeal carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

November 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

November 13, 2015

Last Update Submit

May 25, 2016

Conditions

Nasopharyngeal Carcinoma

Keywords

NPCconcurrent chemotherapydocetaxelcisplatin

Outcome Measures

Primary Outcomes (1)

  • overall survival

    two year

Secondary Outcomes (4)

  • failure-free survival

    two year

  • distant metastasis-free survival

    two year

  • locoregional relapse-free survival

    two year

  • Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0

    up to two months

Study Arms (2)

TP plus IMRT

EXPERIMENTAL

Concurrent chemotherapy: TP - Docetaxel 60mg/m2, D1 and cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy

Drug: DocetaxelDrug: Cisplatin 1Radiation: Intensity-modulated radiotherapy

DDP plus IMRT

ACTIVE COMPARATOR

Concurrent chemotherapy: DDP - Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles; Radiation: Intensity-modulated radiotherapy

Drug: Cisplatin 2Radiation: Intensity-modulated radiotherapy

Interventions

Cisplatin 2DRUG

Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles

Also known as: DDP
DDP plus IMRT
DocetaxelDRUG

Docetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles

Also known as: T
TP plus IMRT
Cisplatin 1DRUG

Cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles

Also known as: P
TP plus IMRT
Intensity-modulated radiotherapyRADIATION

Intensity-modulated radiotherapy

Also known as: IMRT
DDP plus IMRTTP plus IMRT

Eligibility Criteria

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

You may qualify if:

  • Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
  • Tumor staged as T1N3M0, T2-3N2-3M0 or T4N0-3M0 (the 2010 UICC/AJCC staging system).
  • Pretreatment EBV DNA ≥ 1500 copies/mL.
  • Karnofsky scale (KPS) ≥ 70.
  • Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
  • Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
  • Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
  • Patients must give written informed consent.

You may not qualify if:

  • Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  • Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  • History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
  • Prior radiotherapy, 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 University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (10)

  • Zhang LN, Gao YH, Lan XW, Tang J, OuYang PY, Xie FY. Effect of taxanes-based induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: A large scale propensity-matched study. Oral Oncol. 2015 Oct;51(10):950-6. doi: 10.1016/j.oraloncology.2015.07.004. Epub 2015 Jul 21.

    PMID: 26209065BACKGROUND

  • Xie FY, Zou GR, Hu WH, Qi SN, Peng M, Li JS. [Induction chemotherapy with docetaxel plus cisplatin (TP regimen) followed by concurrent chemoradiotherapy with TP regimen versus cisplatin in treating locally advanced nasopharyngeal carcinoma]. Ai Zheng. 2009 Mar;28(3):279-85. Chinese.

    PMID: 19619443BACKGROUND

  • Tishler RB, Schiff PB, Geard CR, Hall EJ. Taxol: a novel radiation sensitizer. Int J Radiat Oncol Biol Phys. 1992;22(3):613-7. doi: 10.1016/0360-3016(92)90888-o.

    PMID: 1346533BACKGROUND

  • Tishler RB, Geard CR, Hall EJ, Schiff PB. Taxol sensitizes human astrocytoma cells to radiation. Cancer Res. 1992 Jun 15;52(12):3495-7.

    PMID: 1350755BACKGROUND

  • Komatsu M, Shiono O, Taguchi T, Sakuma Y, Nishimura G, Sano D, Sakuma N, Yabuki K, Arai Y, Takahashi M, Isitoya J, Oridate N. Concurrent chemoradiotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with locally advanced squamous cell carcinoma of the head and neck. Jpn J Clin Oncol. 2014 May;44(5):416-21. doi: 10.1093/jjco/hyu026. Epub 2014 Mar 30.

    PMID: 24688084BACKGROUND

  • Inohara H, Takenaka Y, Yoshii T, Nakahara S, Yamamoto Y, Tomiyama Y, Seo Y, Isohashi F, Suzuki O, Yoshioka Y, Sumida I, Ogawa K. Phase 2 study of docetaxel, cisplatin, and concurrent radiation for technically resectable stage III-IV squamous cell carcinoma of the head and neck. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):934-41. doi: 10.1016/j.ijrobp.2014.12.032.

    PMID: 25832686BACKGROUND

  • Higuchi K, Komori S, Tanabe S, Katada C, Azuma M, Ishiyama H, Sasaki T, Ishido K, Katada N, Hayakawa K, Koizumi W; Kitasato Digestive Disease and Oncology Group. Definitive chemoradiation therapy with docetaxel, cisplatin, and 5-fluorouracil (DCF-R) in advanced esophageal cancer: a phase 2 trial (KDOG 0501-P2). Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):872-9. doi: 10.1016/j.ijrobp.2014.03.030. Epub 2014 May 24.

    PMID: 24867539BACKGROUND

  • Chen X, Hong Y, Feng J, Ye J, Zheng P, Guan X, You X, Song H. Concurrent chemoradiotherapy comparison of taxanes and platinum versus 5-fluorouracil and platinum in nasopharyngeal carcinoma treatment. Chin Med J (Engl). 2014;127(1):142-9.

    PMID: 24384440BACKGROUND

  • Baykara M, Buyukberber S, Ozturk B, Coskun U, Kaplan MA, Unsal DK, Dane F, Demirci U, Bora H, Benekli M; Anatolian Society of Medical Oncology. Efficacy and safety of concurrent chemoradiotherapy with cisplatin and docetaxel in patients with locally advanced nasopharyngeal cancers. Tumori. 2013 Jul-Aug;99(4):469-73. doi: 10.1177/030089161309900405.

    PMID: 24326834BACKGROUND

  • 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: 25957714BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

cisplatin-guanosine adductDocetaxelSSRP1 protein, humanRadiotherapy, Intensity-Modulated

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)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Fang-Yun Xie, M.D.

    Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang-Yun Xie, M.D.

CONTACT

+86-020-87342618xiefy@sysucc.org.cn

Pu-Yun OuYang, M.D.

CONTACT

+86-020-87342618ouyangpy@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 20, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2020

Study Completion

January 1, 2022

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

CN(1)