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Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.

Primary Purpose

Nasopharyngeal Neoplasms, Mortality, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hyperfractionated IMRT
Conventional Fraction IMRT
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Neoplasms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • histologically approved WHO III patients received radical radiotherapy initially before recurrence (irradiation dosage > 66 Gy).

the interval time between initial treatment and relapse more than 1 year. recurrent Tumor stage2-4(rT2-4) Node stage0-2(rN0-2) Metastasis stage0(rM0) (rT2-4N0-2M0), overall stage II-IVa according to 2009 American Joint Committee on Cancer (AJCC/UICC) Tumor, Node, and Metastasis (TNM) staging system.

a Karnofsky performance status (KPS) score more than 70.

Exclusion Criteria:

  • a history of previous or synchronous malignant tumors. recurrent Node stage3(rN3), recurrent Metastasis stage1(rM1) according to 2009 AJCC/UICC TNM staging system.

positive surgical margin after neck dissection. patients suffered with severe mental illness. severe diseases of the lung and cardiovascular system. severe hepatic and renal dysfunction.

Sites / Locations

  • Sun Yat-sen University Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hyperfractionated IMRT Group

Conventional Fraction IMRT Group

Arm Description

IMRT (total dose of 65Gy, division 54 times, twice a day, once 1.2Gy, irradiation interval of 6-8 hours)

IMRT (total dose of 60Gy, division 27 times, once a day, every 2.2Gy)

Outcomes

Primary Outcome Measures

Overall survival rate
Severe late complications rate

Secondary Outcome Measures

Quality of life questionnaire
Loco-regional relapse free survival rate
Distant metastasis free survival rate

Full Information

First Posted
May 25, 2015
Last Updated
March 21, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02456506
Brief Title
Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.
Official Title
Multiple Centre, Randomised, Controlled Trial of Hyperfractionated IMRT and Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the hyperfractionated IMRT in the treatment of patients with locally recurrent nasopharyngeal carcinoma. Half of participants will receive hyperfractionated IMRT, while the other half will receive conventional fraction IMRT.
Detailed Description
Local recurrence is one of the most challenging issues faced with nasopharyngeal carcinoma (NPC) patients. 8.4% to 10.9% of the patients developed recurrent diseases at the primary or/and regional site after definitive radiotherapy. Although some patients with limited recurrent lesions underwent surgery, the main treatment for these recurrent NPC patients was still re-irradiation. Multiple retrospective and prospective studies have reported: under the condition of conventional fraction IMRT with the total dose of 60 gray (Gy) (division 27 times, once a day, every 2.2Gy), you can get a better local tumor control rate and survival outcome. However, the patients still underwent some severe late complications including nasopharyngeal necrosis, nasopharyngeal bleeding, temporal lobe necrosis, with the incidence rates of 28.8%, 18.6%, 20.3%, respectively. Approximately 50% of recurrent NPC patients died of these severe late complications, significantly compromising the overall survival rate of the patients. Previous studies showed that hyperfractionated radiotherapy could reduce severe late complication rates significantly, without affecting the local control rate. Indeed, we found that under the condition of equal irradiation time and tumor equivalent dosage between hyperfractionated IMRT (total dose of 65Gy, division 54 times, twice a day, once 1.2Gy, irradiation interval of 6-8 hours) and conventional fraction IMRT (total dose of 60Gy, division 27 times, once a day, every 2.2Gy), the normal late responding tissues equivalent dosage( EQD2) significantly decreased compared with conventional fraction IMRT. Therefore, the use of hyperfractionated IMRT is expected to decrease severe late complications rates, thereby improving the quality of life and overall survival of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms, Mortality, Quality of Life, Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hyperfractionated IMRT Group
Arm Type
Experimental
Arm Description
IMRT (total dose of 65Gy, division 54 times, twice a day, once 1.2Gy, irradiation interval of 6-8 hours)
Arm Title
Conventional Fraction IMRT Group
Arm Type
Active Comparator
Arm Description
IMRT (total dose of 60Gy, division 27 times, once a day, every 2.2Gy)
Intervention Type
Radiation
Intervention Name(s)
Hyperfractionated IMRT
Intervention Type
Radiation
Intervention Name(s)
Conventional Fraction IMRT
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
3 year
Title
Severe late complications rate
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Quality of life questionnaire
Time Frame
2 year
Title
Loco-regional relapse free survival rate
Time Frame
3 year
Title
Distant metastasis free survival rate
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: histologically approved WHO III patients received radical radiotherapy initially before recurrence (irradiation dosage > 66 Gy). the interval time between initial treatment and relapse more than 1 year. recurrent Tumor stage2-4(rT2-4) Node stage0-2(rN0-2) Metastasis stage0(rM0) (rT2-4N0-2M0), overall stage II-IVa according to 2009 American Joint Committee on Cancer (AJCC/UICC) Tumor, Node, and Metastasis (TNM) staging system. a Karnofsky performance status (KPS) score more than 70. Exclusion Criteria: a history of previous or synchronous malignant tumors. recurrent Node stage3(rN3), recurrent Metastasis stage1(rM1) according to 2009 AJCC/UICC TNM staging system. positive surgical margin after neck dissection. patients suffered with severe mental illness. severe diseases of the lung and cardiovascular system. severe hepatic and renal dysfunction.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming-Yuan Chen, MD, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yi Pan, MD, PhD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dong-Ping Chen, MD, PhD
Organizational Affiliation
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
10227432
Citation
Cummings BJ. Benefits of accelerated hyperfractionation for head and neck cancer. Acta Oncol. 1999;38(2):131-6. doi: 10.1080/028418699431528.
Results Reference
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PubMed Identifier
15241530
Citation
Jereczek-Fossa BA, Morra A, DeBraud F, Alterio D, Mazzetta C, Rocca A, Catalano G, Bianchi L, Pasetti M, Chiesa F, Bruschini R, Orecchia R. Hyperfractionated radiotherapy in locally advanced nasopharyngeal cancer. An analysis of 43 consecutive patients. Strahlenther Onkol. 2004 Jul;180(7):425-33. doi: 10.1007/s00066-004-1202-9.
Results Reference
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PubMed Identifier
12023138
Citation
Jian JJ, Cheng SH, Tsai SY, Yen KC, Chu NM, Chan KY, Tan TD, Cheng JC, Lin YC, Leu SY, Hsieh CI, Tsou MH, Lin CY, Huang AT. Improvement of local control of T3 and T4 nasopharyngeal carcinoma by hyperfractionated radiotherapy and concomitant chemotherapy. Int J Radiat Oncol Biol Phys. 2002 Jun 1;53(2):344-52. doi: 10.1016/s0360-3016(02)02709-8.
Results Reference
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PubMed Identifier
10225700
Citation
Toita T, Ogawa K, Kamata M, Kojya S, Itokazu T, Kakinohana Y, Iraha S, Yoshinaga M, Zukeran Y, Sawada S. Hyperfractionated radiotherapy followed by adjuvant chemotherapy for nasopharyngeal cancer: report of seven cases. Jpn J Clin Oncol. 1999 Mar;29(3):160-3. doi: 10.1093/jjco/29.3.160.
Results Reference
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Hyperfractionated Intensity-modulated Radiotherapy (IMRT) Versus Conventional Fraction IMRT for Patients With Loco-regionally Recurrent Nasopharyngeal Carcinoma.

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