Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03020329
• Other study ID #: NPC in Young Patients
• Status: Recruiting
• Phase: Phase 2
• Start date: November 14, 2016
• Est. completion date: December 30, 2022

Study information

• Verified date: August 2019
• Source: Sun Yat-sen University
• Contact: DongHua Luo, MD,PhD
• Phone: 8620-87343643
• Email: luodh[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

This phase II trial is studying how well radiation therapy and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma
• Children
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Paclitaxel liposome
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.
• Cisplatin
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.
• 5-fu
Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.

Radiation:
• Radical radiotherapy
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Varan A, Ozyar E, Corapçioglu F, Köksal Y, Aydin B, Yazici N, Akyüz C, Büyükpamukçu 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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival(OS)	The OS was defined as the duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.	3-year
Secondary	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-year
Secondary	Locoregional failure-free survival(LRFS)	The LRFS is evaluated and calculated from the date of random assignment until the day of first locoregional relapse or until the date of the last follow-up visit	3-year
Secondary	Distant metastasis-free survival(DMFS)	The DMFS is evaluated and calculated from the date of random assignment until the day of first distant metastases or until the date of the last follow-up visit	3-year
Secondary	Short-term toxic effects assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)	The shortterm toxic effects were assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0)	3 months
Secondary	Long-term toxicities	QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTCQLQ-C30)	Through study completion, an average of half year
Secondary	Long-term toxicities	EORTC quality of life questionnaire(QLQ) Head and Neck	Through study completion, an average of half year
Secondary	Growth	Patients will be monitored for height(in metre)	Through study completion, an average of half year
Secondary	Growth	Patients will be monitored for weight(in kilogram)	Through study completion, an average of half year
Secondary	Growth	Patients will be monitored for BMI(in kg/m^2)	Through study completion, an average of half year
Secondary	Sex Development	Sex hormone(estrogen,testosterone) levels(in nmol/L)	Through study completion, an average of half year
Secondary	Sex Development	Secondary sex characteristic survey	Through study completion, an average of half year
Secondary	Intelligence Development	Intelligence quotient by Stanford-Binet test	Through study completion, an average of half year

External Links

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