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

Brief Title

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

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

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival rate

Condition

Nasopharyngeal Carcinoma

Intervention

Intensity modulated radiotherapy

Study Arms / Comparison Groups

 IMRT group

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Radiation

Estimated Enrollment

Start Date

March 2017

Completion Date

September 2021

Primary Completion Date

September 2019

Eligibility Criteria

        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.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 18602062748, [email protected]

Administrative Informations

NCT ID

NCT03068936

Organization ID

C1033400

Responsible Party

Sponsor

Study Sponsor

Nanfang Hospital of Southern Medical University

Study Sponsor

, ,

Verification Date

September 2016