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

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Radiation: Intensity modulated radiotherapy; Drug: Cisplatin

• Registration Number: NCT03068936
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Study Start: 2017-03
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03
• Primary Completion: 2019-09
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 716

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMRT group	Intensity modulated radiotherapy	Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
IMRT plus cisplatin group	Intensity modulated radiotherapy	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
IMRT plus cisplatin group	Cisplatin	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

Primary Outcome Measures

Name	Time	Method
Overall survival rate	up to 3 years	Refers to the time from included to death due to any cause.