Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, Stage II, Intensity-modulated radiotherapy, Concurrent chemoradiotherapy, Cisplatin
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.
Interventions
DRUGcisplatin
in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicities | 2 years | Acute toxicity will be measured by CTCAE3.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Long term treatment results | 5 years | 1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed. |
Countries
China
Outcome results
None listed