- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01817023
The Role of Concurrent Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma(NPC) in the Era of IMRT
January 28, 2021 updated by: Jun-Lin Yi, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
590
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Junlin YI, MD
- Phone Number: 861087788504
- Email: yijunlin1969@163.com
Study Contact Backup
- Name: Kai Wang, MD
- Phone Number: 8613910741366
- Email: kaiwang2007@163.com
Study Locations
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-
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Beijing, China, 100021
- Recruiting
- Cancer Hospital, Chinese Academy of Medical Sciences
-
Contact:
- Junlin YI, MD
- Phone Number: 861087788504
- Email: yijunlin1969@163.com
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510060
- Not yet recruiting
- Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University
-
Contact:
- Xiang Guo, MD
- Phone Number: 8613902251681
- Email: guoxiang@sysucc.org.cn
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Guangzhou, Guangdong, China, 510060
- Recruiting
- Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University
-
Contact:
- Chong Zhao, MD
- Phone Number: 8613902206160
- Email: zhaochong@sysucc.org.cn
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-
Hubei
-
Wuhan, Hubei, China, 430030
- Not yet recruiting
- Zhongnan Hospital of Wuhan University
-
Contact:
- Conghua Xie, MD
- Phone Number: 8613638607566
- Email: chxie_65@hotmail.com
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Wuhan, Hubei, China, 430032
- Recruiting
- Tongji hospital, Huazhong University of Science & Technology
-
Contact:
- Guoqing Hu, MD
- Phone Number: 8613707189803
- Email: gqhu@tjh.tjmu.edu.cn
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-
Jiangxi
-
Nanchang, Jiangxi, China, 330029
- Not yet recruiting
- Jiangxi Province Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RT alone
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
|
Active Comparator: CCRT group
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.
|
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
Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival
Time Frame: 5 years
|
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
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute and late toxicities
Time Frame: 5years
|
|
5years
|
3 year Progression-free survival (PFS)
Time Frame: 5year
|
to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy
|
5year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Li Gao, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
July 30, 2019
Study Completion (Anticipated)
March 30, 2021
Study Registration Dates
First Submitted
March 20, 2013
First Submitted That Met QC Criteria
March 20, 2013
First Posted (Estimate)
March 22, 2013
Study Record Updates
Last Update Posted (Actual)
January 29, 2021
Last Update Submitted That Met QC Criteria
January 28, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
- Antineoplastic Agents
- Cisplatin
Other Study ID Numbers
- CH-HN-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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