Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

NCT03020329 | Unknown Phase 2 DMC

• 1 other identifier: NPC in Young Patients
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

1\. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).

Conditions

Nasopharyngeal Carcinoma; Children

Keywords

Induction Chemotherapy; Nasopharyngeal carcinoma; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR)

  CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the chemoradiotherapy treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only

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

Secondary Outcomes (13)

• Overall survival(OS)

  3-year

• Progress-free survival(PFS)

  3-year

• Locoregional failure-free survival(LRFS)

  3-year

• Distant metastasis-free survival(DMFS)

  3-year

• Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)

  3 months

Study Arms (1)

Paclitaxel liposome, Cisplatin, 5-Fu,

EXPERIMENTAL

Patients receive paclitaxel liposome(135mg/m2 on day 1), cisplatin (75mg/m2 on day 1,Separate injection on day 1 to 3) and fluorouracil (3750mg/m2 CIV 120h) every three weeks for three cycles before the radiotherapy, and then receive radical radiotherapy(Intensive modulate radiotherapy,IMRT)and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Drug: Paclitaxel liposome; Drug: Cisplatin; Drug: 5-fu; Radiation: Radical radiotherapy

Interventions

Paclitaxel liposome DRUG

Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy. Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily.

Also known as: Paclitaxel liposome,cisplatin,fluorouracil(TPF) chemotherapy

Paclitaxel liposome, Cisplatin, 5-Fu,

Cisplatin DRUG

Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.

Also known as: TPF induction chemotherapy, Concurrent cisplatin

Paclitaxel liposome, Cisplatin, 5-Fu,

5-fu DRUG

Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.

Also known as: TPF induction chemotherapy

Paclitaxel liposome, Cisplatin, 5-Fu,

Radical radiotherapy RADIATION

Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.

Also known as: Concurrent radiotherapy

Paclitaxel liposome, Cisplatin, 5-Fu,

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
• Original clinical staged as T4N0-3 M0 or any T、N3M0（according to the American Joint Committee on Cancer(AJCC) 7th edition）
• No evidence of distant metastasis (M0).
• Age ≤ 18 years old.
• Satisfactory performance status: Karnofsky scale (KPS) \> 70.
• 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 years.
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (12)

• Daoud J, Ghorbal L, Siala W, Elloumi F, Ghorbel A, Frikha M. [Is there any difference in therapeutic results of nasopharyngeal carcinoma between adults and children?]. Cancer Radiother. 2013 Dec;17(8):763-7. doi: 10.1016/j.canrad.2013.06.046. Epub 2013 Nov 20. French.

  PMID: 24269016 BACKGROUND

• Yan Z, Xia L, Huang Y, Chen P, Jiang L, Zhang B. Nasopharyngeal carcinoma in children and adolescents in an endemic area: a report of 185 cases. Int J Pediatr Otorhinolaryngol. 2013 Sep;77(9):1454-60. doi: 10.1016/j.ijporl.2013.06.005. Epub 2013 Jul 3.

  PMID: 23830224 BACKGROUND

• Liao WW, Tang SQ, Liu Y, Feng C. [Treatment of nasopharyngeal carcinoma in children]. Zhongguo Dang Dai Er Ke Za Zhi. 2013 Apr;15(4):273-6. Chinese.

  PMID: 23607949 BACKGROUND

• Hu S, Xu X, Xu J, Xu Q, Liu S. Prognostic factors and long-term outcomes of nasopharyngeal carcinoma in children and adolescents. Pediatr Blood Cancer. 2013 Jul;60(7):1122-7. doi: 10.1002/pbc.24458. Epub 2013 Jan 9.

  PMID: 23303571 BACKGROUND

• Cheuk DK, Billups CA, Martin MG, Roland CR, Ribeiro RC, Krasin MJ, Rodriguez-Galindo C. Prognostic factors and long-term outcomes of childhood nasopharyngeal carcinoma. Cancer. 2011 Jan 1;117(1):197-206. doi: 10.1002/cncr.25376. Epub 2010 Aug 24.

  PMID: 20737561 BACKGROUND

• Buehrlen M, Zwaan CM, Granzen B, Lassay L, Deutz P, Vorwerk P, Staatz G, Gademann G, Christiansen H, Oldenburger F, Tamm M, Mertens R. Multimodal treatment, including interferon beta, of nasopharyngeal carcinoma in children and young adults: preliminary results from the prospective, multicenter study NPC-2003-GPOH/DCOG. Cancer. 2012 Oct 1;118(19):4892-900. doi: 10.1002/cncr.27395. Epub 2012 Feb 22.

  PMID: 22359313 BACKGROUND

• Shen C, Gao Y, Xu T, Wang X, Ying H, Hu C. Carcinoma of the nasopharynx in young patients: a single institution experience. Clin Oncol (R Coll Radiol). 2009 Oct;21(8):617-22. doi: 10.1016/j.clon.2009.07.005. Epub 2009 Aug 5.

  PMID: 19660923 BACKGROUND

• Varan A, Ozyar E, Corapcioglu F, Koksal Y, Aydin B, Yazici N, Akyuz C, Buyukpamukcu M. Pediatric and young adult nasopharyngeal carcinoma patients treated with preradiation Cisplatin and docetaxel chemotherapy. Int J Radiat Oncol Biol Phys. 2009 Mar 15;73(4):1116-20. doi: 10.1016/j.ijrobp.2008.05.028. Epub 2008 Sep 9.

  PMID: 18786778 BACKGROUND

• Laskar S, Bahl G, Muckaden M, Pai SK, Gupta T, Banavali S, Arora B, Sharma D, Kurkure PA, Ramadwar M, Viswanathan S, Rangarajan V, Qureshi S, Deshpande DD, Shrivastava SK, Dinshaw KA. Nasopharyngeal carcinoma in children: comparison of conventional and intensity-modulated radiotherapy. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):728-36. doi: 10.1016/j.ijrobp.2008.01.032. Epub 2008 Apr 18.

  PMID: 18374512 BACKGROUND

• Selek U, Ozyar E, Ozyigit G, Varan A, Buyukpamukcu M, Atahan IL. Treatment results of 59 young patients with nasopharyngeal carcinoma. Int J Pediatr Otorhinolaryngol. 2005 Feb;69(2):201-7. doi: 10.1016/j.ijporl.2004.09.001.

  PMID: 15656953 BACKGROUND

• Orbach D, Brisse H, Helfre S, Klijanienko J, Bours D, Mosseri V, Rodriguez J. Radiation and chemotherapy combination for nasopharyngeal carcinoma in children: Radiotherapy dose adaptation after chemotherapy response to minimize late effects. Pediatr Blood Cancer. 2008 Apr;50(4):849-53. doi: 10.1002/pbc.21372.

  PMID: 17973328 BACKGROUND

• Ahern V, Jenkin D, Banerjee D, Greenberg M, Payne D. Nasopharyngeal carcinoma in the young. Clin Oncol (R Coll Radiol). 1994;6(1):24-30. doi: 10.1016/s0936-6555(05)80364-4.

  PMID: 8172830 BACKGROUND

Related Links

• cisplatin
• amifostine
• paclitaxel
• fluorouracil
• nasopharyngeal carcinoma
• young patients

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Drug Therapy; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• HaiQiang Mai, MD,PhD

  Cancer center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DongHua Luo, MD,PhD

CONTACT

8620-87343643; luodh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Deputy Director

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: January 13, 2017
• Study Start: November 14, 2016
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2022
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)