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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03068936
• Other study ID #: C1033400
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 15, 2017
• Last updated: February 27, 2017
• Start date: March 2017
• Est. completion date: September 2021

Study information

• Verified date: September 2016
• Source: Nanfang Hospital of Southern Medical University
• Contact: Dehua Wu
• Phone: 18602062748
• Email: 18602062748[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 716
• Est. completion date: September 2021
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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

Drug:
• Cisplatin
Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Refers to the time from included to death due to any cause.	up to 3 years