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

Purpose

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.

Condition	Intervention	Phase
Nasopharyngeal Carcinoma	Radiation: SIB-IMRT Drug: Cisplatin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:

overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute and late toxicities [ Time Frame: 5years ] [ Designated as safety issue: Yes ]
- compare the acute radiation and chemotherapy-related toxicities during treatment course
- compare late toxicities after treatment
3 year Progression-free survival (PFS) [ Time Frame: 5year ] [ Designated as safety issue: No ]
to compare the 3years PFS between the IMRT alone and IMRT with concurrent chemoradiotherapy

Estimated Enrollment:	590
Study Start Date:	April 2013
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Radiation: SIB-IMRT 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.	Radiation: SIB-IMRT 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 Drug: Cisplatin Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01817023

Contacts

Contact: Junlin YI, MD	861087788504	junlinyi@sohu.com
Contact: Kai Wang, MD	8613910741366	kaiwang2001@vip.sina.com

Locations

China, Guangdong
Department of Radiation oncology, Cancer hospital, Sun Yat-Sen University	Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Chong Zhao, MD 8613902206160 zhaochong@sysucc.org.cn
Department of nasopharyngeal carcinoma, Cancer hospital, Sun Yat-Sen University	Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xiang Guo, MD 8613902251681 guoxiang@sysucc.org.cn
China, Hubei
Tongji hospital, Huazhong University of Science & Technology	Not yet recruiting
Wuhan, Hubei, China, 430032
Contact: Guoqing Hu, MD 8613707189803 gqhu@tjh.tjmu.edu.cn
Zhongnan Hospital of Wuhan University	Not yet recruiting
Wuhan, Hubei, China, 430030
Contact: Conghua Xie, MD 8613638607566 chxie_65@hotmail.com
China, Jiangxi
Jiangxi province cancer hospital	Not yet recruiting
Nanchang, Jiangxi, China, 330029
Contact: Jingao Li, MD 8613970866296 lijingao@hotmail.com
China
Cancer hospital, Chinese Academy of Medical Sciences	Recruiting
Beijing, China, 100021
Contact: Junlin YI, MD 861087788504 junlinyi@sohu.com

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Investigators

Principal Investigator:

Li Gao, MD

Cancer Hospital, Chinese Academy of Medical Sciences

More Information

No publications provided

Responsible Party:	Li Gao, Vice chairman， Department of Radiation Oncology, Cancer hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01817023 History of Changes
Other Study ID Numbers:	CH-HN-003
Study First Received:	March 20, 2013
Last Updated:	March 26, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:

Nasopharyngeal carcinoma
current chemotherapy
intensity-modulated radiotherapy
low-risk

Additional relevant MeSH terms:

Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Carcinoma

Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013