Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma
18 Years
70 Years
Both
Nasopharyngeal Carcinoma
Trial Information
Multicenter Phase III Study of Intensity-modulated Radiotherapy Alone Compared to Intensity-modulated Radiotherapy Combined Chemotherapy for Lower Risk Locally Advanced Nasopharyngeal Carcinoma
- 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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
overall survival
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Li Gao, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Hospital, Chinese Academy of Medical Sciences
Authority:
China: Food and Drug Administration
Study ID:
CH-HN-003
NCT ID:
NCT01817023
Start Date:
April 2013
Completion Date:
April 2018
Related Keywords:
- Nasopharyngeal Carcinoma
- Nasopharyngeal carcinoma
- current chemotherapy
- intensity-modulated radiotherapy
- low-risk
- Carcinoma
- Nasopharyngeal Neoplasms
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