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

Primary Purpose

Effects of Chemotherapy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Concurrent chemotherapy with cisplatin
Intensity modulated radiotherapy
Sponsored by
Cancer Hospital of Guangxi Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effects of Chemotherapy focused on measuring Nasopharyngeal neoplasm;IMRT; Concurrent chemotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cancer Hospital of Guangxi Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent chemoradiotherapy

IMRT alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Failure-free survival (FFS)
The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.

Secondary Outcome Measures

Overall survival (OS)
The time is calculated from the date of diagnosis to the date of patient death.
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.
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.
Acute and late adverse events
The side effects will be evaluated according to CTCAE V 3.0.

Full Information

First Posted
April 2, 2014
Last Updated
April 15, 2014
Sponsor
Cancer Hospital of Guangxi Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02116231
Brief Title
The Role of Adding Concurrent Chemotherapy to IMRT in the Treatment of Stage II Nasopharyngeal Carcinoma
Official Title
Phase II Study Comparing Intensity Modulated Radiotherapy (IMRT) in Combination With Concurrent Chemotherapy and IMRT Alone for Stage II Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Hospital of Guangxi Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effects of Chemotherapy
Keywords
Nasopharyngeal neoplasm;IMRT; Concurrent chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent chemoradiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
IMRT alone
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Concurrent chemotherapy with cisplatin
Intervention Description
Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT
Intervention Type
Radiation
Intervention Name(s)
Intensity modulated radiotherapy
Intervention Description
Intensity modulated radiotherapy is a technique of radiotherapy.
Primary Outcome Measure Information:
Title
Failure-free survival (FFS)
Description
The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
The time is calculated from the date of diagnosis to the date of patient death.
Time Frame
One year
Title
Loco-regional failure-free survival (LFFS)
Description
The time is calculated from the date of diagnosis to the date of a relapse of local or nodal tumors.
Time Frame
One year
Title
Distant metastasis failure-free survival (DMFS)
Description
The time is calculated from the date of diagnosis to the date of occurrence of relapse or distant metastasis.
Time Frame
One year
Title
Acute and late adverse events
Description
The side effects will be evaluated according to CTCAE V 3.0.
Time Frame
Four months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaodong Zhu, Doctor
Email
zhuxiaodong83@163.com
Facility Information:
Facility Name
Cancer Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhu, Doctor
Email
zhuxiaodong83@163.com
First Name & Middle Initial & Last Name & Degree
Song Qu, Doctor
First Name & Middle Initial & Last Name & Degree
Ling Li, Master

12. IPD Sharing Statement

Citations:
PubMed Identifier
21592702
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.
Results Reference
background
PubMed Identifier
12176778
Citation
Chan AT, Teo PM, Johnson PJ. Nasopharyngeal carcinoma. Ann Oncol. 2002 Jul;13(7):1007-15. doi: 10.1093/annonc/mdf179.
Results Reference
background
PubMed Identifier
21801605
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.
Results Reference
background
PubMed Identifier
20395788
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.
Results Reference
background
Links:
URL
http://www.gxmu.edu.cn/
Description
Guangxi Medical University

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

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