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The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

Primary Purpose

Nasopharyngeal Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

SIB-IMRT

Cisplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, current chemotherapy, intensity-modulated radiotherapy, low-risk

Eligibility Criteria

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

Inclusion Criteria:

Histopathological proven non-keratin nasopharyngeal carcinoma
AJCC 7th edition stage III/IVM0, without any one of following factors: node size >6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node >4 cm
Life expectancy≥6 months
Adequate renal function, defined as follows: Serum creatinine < 2 x institutional upper limit of normal(ULN) within 2 weeks prior to registration or creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCrmale)
The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin

Exclusion Criteria:

Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Severe, active co-morbidity
Treatment planning does not meet the requirement of prescription dose.

Sites / Locations

Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University
Department of Radiation oncology, Cancer hospital, Sun Yat-Sen UniversityRecruiting
Zhongnan Hospital of Wuhan University
Tongji hospital, Huazhong University of Science & TechnologyRecruiting
Jiangxi province cancer hospital
Cancer hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RT alone

CCRT group

Arm Description

SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume

SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume and cisplatin 100mg/m2 was given at d1, d22,d43 during radiotherapy.

Outcomes

Primary Outcome Measures

overall survival

according to the recruitment, a interrim analysis will done in July, 2019, if there is inferior finding of RT alone group, the study will premature terminate

Secondary Outcome Measures

Acute and late toxicities

compare the acute radiation and chemotherapy-related toxicities during treatment course compare late toxicities after treatment

3 year Progression-free survival (PFS)

to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy

Full Information

NCT ID

NCT01817023

First Posted

March 20, 2013

Last Updated

January 28, 2021

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01817023

Brief Title

The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

Official Title

Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Unknown status

Study Start Date

April 2013 (undefined)

Primary Completion Date

July 30, 2019 (Actual)

Study Completion Date

March 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to verify that simultaneous integrated boost IMRT (SIB-IMRT) alone is non-inferior to SIB-IMRT combined with concurrent chemotherapy for low-risk locally advanced nasopharyngeal carcinoma.

Detailed Description

There were several randomized clinical trials confirmed that concurrent chemoradiotherapy (CCRT) is superior to radiotherapy (RT)alone for locally advanced NPC, most of the patients in the trials were treated with conventional radiotherapy technique. As the new technique of IMRT used more and more in the clinical practice, the role of concurrent chemoradiotherapy (CCRT) seems blurred, in two of Hongkong phaseIII studies(NPC9901/9902), half of the patients were treated by 3-dimensional conformal radiotherapy (3DCRT)/IMRT,the results showed that there were no significant different in terms of overall survival between RT alone and CCRT groups. Furthermore, several large sample size retrospective studies from China, showed that there were no advantage of CCRT over RT alone when treated by SIB-IMRT. In an analysis of who will benefit from CCRT,( Lin, et.al, IJROBP,2004; 60:156-164), the author divided the locally advanced NPC patients into two groups, with the high-risk group defined as patients met at least one of following criteria: nodal size >6 cm, (2) supraclavicular node metastasesN3, T4N2 and multiple neck node metastases with 1 node >4cm. Based on these information, we hypothesize that, for low-risk locally advanced NPC patients, there may no need CCRT under SIB-IMRT treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, current chemotherapy, intensity-modulated radiotherapy, low-risk

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Masking Description

central investigator organization digital randomize

Allocation

Randomized

Enrollment

590 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RT alone

Arm Type

Experimental

Arm Description

SIB-IMRT was given to the patients with a regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume

Arm Title

CCRT group

Arm Type

Active Comparator

Arm Description

Intervention Type

Radiation

Intervention Name(s)

SIB-IMRT

Intervention Description

SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Intervention Description

Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.

Primary Outcome Measure Information:

Title

overall survival

Description

according to the recruitment, a interrim analysis will done in July, 2019, if there is inferior finding of RT alone group, the study will premature terminate

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Acute and late toxicities

Description

compare the acute radiation and chemotherapy-related toxicities during treatment course compare late toxicities after treatment

Time Frame

5years

Title

3 year Progression-free survival (PFS)

Description

to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy

Time Frame

5year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histopathological proven non-keratin nasopharyngeal carcinoma AJCC 7th edition stage III/IVM0, without any one of following factors: node size >6cm;supraclavicular metastasis node; T4N2; multiple neck node metastases with 1 node >4 cm Life expectancy≥6 months Adequate renal function, defined as follows: Serum creatinine < 2 x institutional upper limit of normal(ULN) within 2 weeks prior to registration or creatinine clearance rate (CCr) ≥ 50 ml/min within 2 weeks prior to registration determined by 24- hour collection or estimated by Cockcroft-Gault formula: CCr male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CCr female = 0.85 x (CCrmale) The following assessments are required within 2 weeks prior to the start of registration: Na, K, Cl, glucose, Ca, Mg, and albumin Exclusion Criteria: Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) are permitted even if diagnosed and treated < 3 years ago Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields Severe, active co-morbidity Treatment planning does not meet the requirement of prescription dose.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Junlin YI, MD

Phone

861087788504

yijunlin1969@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kai Wang, MD

Phone

8613910741366

kaiwang2007@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li Gao, MD

Organizational Affiliation

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiang Guo, MD

Phone

8613902251681

guoxiang@sysucc.org.cn

Facility Name

Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chong Zhao, MD

Phone

8613902206160

zhaochong@sysucc.org.cn

Facility Name

Zhongnan Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430030

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Conghua Xie, MD

Phone

8613638607566

chxie_65@hotmail.com

Facility Name

Tongji hospital, Huazhong University of Science & Technology

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guoqing Hu, MD

Phone

8613707189803

gqhu@tjh.tjmu.edu.cn

Facility Name

Jiangxi province cancer hospital

City

Nanchang

State/Province

Jiangxi

ZIP/Postal Code

330029

Country

China

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingao Li, MD

Phone

8613970866296

lijingao@hotmail.com

Facility Name

Cancer hospital, Chinese Academy of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Junlin YI, MD

Phone

861087788504

yijunlin1969@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT

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