Brief Title
The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma
Official Title
A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma
Brief Summary
The purpose of this study is to verify the role of adding cisplatin chemotherapy to the
intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.
Detailed Description
Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three
subgroups, the data came from conventional radiotherapy era showed that the prognosis of this
three subgroups were different, the N1 groups suffered more distant metastasis than N0 group,
and some literature showed that combined chemotherapy with radiotherapy in stage II patients
can improve the treatment results.
Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of
nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of
life in nasopharyngeal through salivary gland preservation.
Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of
stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup)
nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Acute toxicities
Secondary Outcome
Long term treatment results
Condition
Nasopharyngeal Carcinoma
Intervention
cisplatin
Study Arms / Comparison Groups
Arm1-radical radiotherapy alone group
Description: Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
84
Start Date
May 2010
Completion Date
October 2017
Primary Completion Date
July 2012
Eligibility Criteria
Inclusion Criteria:
- pathological confirmed squamous cell carcinoma, WHO II-III type,
- clinical stage II (UICC 7th edition, 2009)
- Karnovsky performance score > 70
- first course of radiotherapy, without radiotherapy and chemotherapy history for other
head and neck cancer.
- anticipated life span more than 6 month
- Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L
- liver and renal function under the 1.25 normal upper limit
- with written consent information
Exclusion Criteria:
- have other cancer history
- have chemotherapy history
- have radiotherapy history
- have head and neck surgery history(exclusion lymph node biopsy)
- evidence showed distant metastasis or other cancer
- other severe medical comorbidity
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Li Gao, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01187238
Organization ID
CH-HN-001
Responsible Party
Principal Investigator
Study Sponsor
Chinese Academy of Medical Sciences
Study Sponsor
Li Gao, MD, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Verification Date
July 2020