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

NCT02116231 | Unknown Phase 2 DMC

• 1 other identifier: CHGX20140402
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effects of Chemotherapy

Keywords

Nasopharyngeal neoplasm;IMRT; Concurrent chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Overall survival (OS)

  One year

• Loco-regional failure-free survival (LFFS)

  One year

• Distant metastasis failure-free survival (DMFS)

  One year

• Acute and late adverse events

  Four months

Study Arms (2)

Concurrent chemoradiotherapy

EXPERIMENTAL

Concurrent chemoradiotherapy: IMRT was given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy.

Drug: Concurrent chemotherapy with cisplatin; Radiation: Intensity modulated radiotherapy

IMRT alone

ACTIVE COMPARATOR

IMRT is given to the patients with regimen of 66Gy-76Gy to the gross target volume of nasopharynx,66-70Gy to the gross target volume of positive nodes, 60-62Gy the high risk clinical target volume, 50-56Gy to the low risk clinical target volume.

Radiation: Intensity modulated radiotherapy

Interventions

Concurrent chemotherapy with cisplatin DRUG

Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT

Concurrent chemoradiotherapy

Intensity modulated radiotherapy RADIATION

Intensity modulated radiotherapy is a technique of radiotherapy.

Concurrent chemoradiotherapy; IMRT alone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Hospital of Guangxi Medical University: lead

Study Sites (1)

Cancer Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

Related Publications (4)

• 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.

  PMID: 21592702 BACKGROUND

• Chan AT, Teo PM, Johnson PJ. Nasopharyngeal carcinoma. Ann Oncol. 2002 Jul;13(7):1007-15. doi: 10.1093/annonc/mdf179.

  PMID: 12176778 BACKGROUND

• 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.

  PMID: 21801605 BACKGROUND

• 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.

  PMID: 20395788 BACKGROUND

Related Links

• Guangxi Medical University

MeSH Terms

Interventions

Cisplatin; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Central Study Contacts

Xiaodong Zhu, Doctor

CONTACT

zhuxiaodong83@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2018
• Last Updated: April 16, 2014

Record last verified: 2014-04

Locations

CN (1)