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

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Radiation: Intensity modulated radiotherapy; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03068936

C1033400

Details and patient eligibility

About

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.

Enrollment: 716 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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716 participants in 2 patient groups

IMRT group

Experimental group

Description:

Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)

Treatment:

Radiation: Intensity modulated radiotherapy

IMRT plus cisplatin group

Other group

Description:

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

Treatment:

Radiation: Intensity modulated radiotherapy

Drug: Cisplatin