The Role of Adding Concurrent Chemotherapy to IMRT in the Treatment of Stage II Nasopharyngeal Carcinoma

Effects of Chemotherapy Clinical Trial

Official title:

Phase II Study Comparing Intensity Modulated Radiotherapy (IMRT) in Combination With Concurrent Chemotherapy and IMRT Alone for Stage II Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02116231
• Other study ID #: CHGX20140402
• Status: Not yet recruiting
• Phase: Phase 2
• First received: April 2, 2014
• Last updated: April 15, 2014
• Start date: April 2014
• Est. completion date: May 2018

Study information

• Verified date: April 2014
• Source: Cancer Hospital of Guangxi Medical University
• Contact: Xiaodong Zhu, Doctor
• Email: zhuxiaodong83[@]163.com
• Is FDA regulated: No
• Health authority: National Health and Family Planning Commission of the People's Republic of China: China
• Study type: Interventional

Clinical Trial Summary

The study is designed to compare Intensity Modulated Radiotherapy (IMRT) in combination with concurrent chemotherapy and IMRT alone in treatment of stage II nasopharyngeal carcinoma.

Description:

Nasopharyngeal carcinoma (NPC) is endemic in Southern China, Southeast Asia, the Arctic, and mid-East/North Africa. NPC prevalence is reported to be highest in southern China, where an average of 80 cases per 100,000 population are reported each year. It is both radiosensitive and chemosensitive. The National Comprehensive Cancer Network (NCCN) guidelines (version 1, 2013), have recommended use of concurrent chemoradiotherapy (CCRT) with or without adjuvant chemotherapy (AC) as standard treatment for NPC.

Recently, the technique of IMRT has become widely used in the treatment of nasopharyngeal carcinoma. The preliminary results showed that IMRT might improve the rate of local control and the quality of life in NPC. In a retrospective study (Ivan,2010), the result showed that IMRT without concurrent chemotherapy provides good outcome for patients with stage IIB NPC with acceptable toxicity. Another study showed that Comparing with IMRT alone, IMRT in combination with chemotherapy provided no significant benefit to locoregionally advanced NPC (Su,2011). With IMRT, it was unclear whether the additional of concurrent chemotherapy was essential for stage II nasopharyngeal carcinoma.

The investigators designed the present study to research the role of adding concurrent chemotherapy to intensity modulated radiotherapy in the treatment of stage II NPC. The primary endpoint is failure-free survival (FFS).The second endpoints were overall survival (OS),loco-regional failure-free survival (LFFS), distant metastasis failure-free survival (DMFS), and acute and late adverse events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: May 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type).

• 18 Years to 70 Years

• Tumor staged as T1-2N1/ T2N0 (according to the 7th AJCC edition),No evidence of distant metastasis (M0)

• Satisfactory performance status: Karnofsky scale (KPS) > 70 (Appendix I ).

• Adequate marrow: leucocyte count > 4×109/L, neutrophil count > 2×109/L, hemoglobin > 90g/L and platelet count > 100×109/L

• 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 > 60 or < 18.

• Treatment with palliative intent.

• 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 RT (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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Effects of Chemotherapy
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Concurrent chemotherapy with cisplatin
Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT

Radiation:
• Intensity modulated radiotherapy
Intensity modulated radiotherapy is a technique of radiotherapy.

Locations

Country	Name	City	State
China	Cancer Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

Chan AT, Teo PM, Johnson PJ. Nasopharyngeal carcinoma. Ann Oncol. 2002 Jul;13(7):1007-15. Review. — View Citation

Su SF, Han F, Zhao C, Huang Y, Chen CY, Xiao WW, Li JX, Lu TX. Treatment outcomes for different subgroups of nasopharyngeal carcinoma patients treated with intensity-modulated radiation therapy. Chin J Cancer. 2011 Aug;30(8):565-73. doi: 10.5732/cjc.010.10547. — View Citation

Tham IW, Lin S, Pan J, Han L, Lu JJ, Wee J. Intensity-modulated radiation therapy without concurrent chemotherapy for stage IIb nasopharyngeal cancer. Am J Clin Oncol. 2010 Jun;33(3):294-9. doi: 10.1097/COC.0b013e3181d2edab. — View Citation

Yoshizaki T, Ito M, Murono S, Wakisaka N, Kondo S, Endo K. Current understanding and management of nasopharyngeal carcinoma. Auris Nasus Larynx. 2012 Apr;39(2):137-44. doi: 10.1016/j.anl.2011.02.012. Epub 2011 May 17. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Failure-free survival (FFS)	The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.	One year	No
Secondary	Overall survival (OS)	The time is calculated from the date of diagnosis to the date of patient death.	One year	No
Secondary	Loco-regional failure-free survival (LFFS)	The time is calculated from the date of diagnosis to the date of a relapse of local or nodal tumors.	One year	No
Secondary	Distant metastasis failure-free survival (DMFS)	The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.	One year	No
Secondary	Acute and late adverse events	The side effects will be evaluated according to CTCAE V 3.0.	Four months	Yes

External Links

•   Guangxi Medical University
•   National Health and Family Planning Commission of the People's Republic of China