IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower. Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.

Official Title
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Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Radiation: Intensity modulated radiotherapy
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The sex of the subject is not limited, the age is from 18 to 70 years old; Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type; Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients； Karnofsky score ≥ 80 points; No evidence of distant metastasis; Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect. Exclusion Criteria: The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ); Previously received immunotherapy; Previously received chemotherapy; Previously received radiation therapy; Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy); Evidence of distant metastases or other malignancies at the same time.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT group<br>Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy) | Radiation: Intensity modulated radiotherapy<br>* Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)<br>* Other names: IMRT;|
| Other: IMRT plus cisplatin group<br>Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy),plus synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times | Radiation: Intensity modulated radiotherapy<br>* Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)<br>* Other names: IMRT;Drug: Cisplatin<br>* Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | Refers to the time from included to death due to any cause. | up to 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, Intensity modulated radiotherapy, Cisplatin