Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Brief Title

Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Official Title

Phase II Randomized Trial Comparing Paclitaxel Combined With DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Brief Summary

      This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent
      Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally
      Advanced Nasopharyngeal Carcinoma
    

Detailed Description

      Nasopharyngeal carcinoma is one of the most common malignancies in South China.
      Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Concurrent
      chemoradiation has become a standard treatment for locally advanced stage III-IVb
      nasopharyngeal carcinoma. However, The recommended single-agent DDP concurrent chemotherapy
      regimen for high-risk patients (IVa-IVb period) to improve the efficacy was not significant.
      Paclitaxel combined with platinum in the same period of chemotherapy regimen has been widely
      used in head and neck cancer, cervical cancer, esophageal squamous cell carcinoma and lung
      cancer and other tumors, a number of studies have shown that it has good tolerance and
      efficacy. And a number of previous studies have shown that paclitaxel combined with platinum
      chemotherapy in the same period of head and neck cancer or nasopharyngeal cancer in multiple
      phase II clinical trials to achieve encouraging results. Based on the above background and
      basis, for the high risk (IVa-IVb) nasopharyngeal carcinoma treatment, the applicant intends
      to carry out the first IMRT + paclitaxel + DDP concurrent chemotherapy compared with DDP
      single drug concurrent chemotherapy regimen Pharyngeal cancer in a prospective randomized
      controlled phase Ⅱ clinical trial for paclitaxel + DDP dual-chemotherapy regimen for the
      treatment of high-risk nasopharyngeal carcinoma to provide evidence-based basis. (IVa-IVb)
      nasopharyngeal carcinoma (NPC), and to provide a high-level evidence-based evidence-based
      approach to the treatment of nasopharyngeal carcinoma at high risk (stage IVa-IVb). The
      results of this study will be used in international guidelines to optimize high- Treatment of
      cancer patients.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

3-year progress free survival(PFS)

Secondary Outcome

 overall survival(OS)

Condition

Nasopharyngeal Carcinoma

Intervention

Paclitaxel

Study Arms / Comparison Groups

 Paclitaxel

Description:  Paclitaxel plus Cisplatin combine with IMRT

Publications

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

Recruitment Status

Drug

Estimated Enrollment

164

Start Date

February 4, 2017

Completion Date

June 1, 2027

Primary Completion Date

December 1, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with newly histologically confirmed non-keratinizing carcinoma.

          2. Patients with newly histologically confirmed non-keratinizing nasopharyngeal
             carcinoma, including WHO II or III.

          3. Original clinical staged as IVa-IVb（according to the 7th AJCC edition）.

          4. Male and no pregnant female

          5. Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1.

          6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L

          7. With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)

          8. With normal renal function test (Creatinine ≤ 1.5×ULN)

          9. Written informed consent.

        Exclusion Criteria:

          1. Patients have evidence of relapse or distant metastasis Histologically confirmed
             keratinizing squamous cell carcinoma (WHO I)

          2. Receiving radiotherapy or chemotherapy previously

          3. The presence of uncontrolled life-threatening illness

          4. Women of child-bearing potential who are pregnant or breastfeeding because of the
             potentially dangerous effects of the preparative chemotherapy on the fetus or infant.

          5. Active systemic infections, coagulation disorders or other major medical illnesses of
             the cardiovascular, respiratory or immune system, myocardial infarction, cardiac
             arrhythmias, obstructive or restrictive pulmonary disease.

             Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency
             Disease).

          6. Concurrent opportunistic infections (The experimental treatment being evaluated in
             this protocol depends on an intact immune system. Patients who have decreased immune
             competence may be less responsive to the experimental treatment and more susceptible
             to its toxicities).

          7. Concurrent systemic steroid therapy

          8. HIV positive

          9. Suffered from other malignant tumors (except the cure of basal cell carcinoma or
             uterine cervical carcinoma in situ) previously
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

China

Location Countries

China

NCT ID

NCT03047265

Organization ID

308-2016-02-01

Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University

Study Sponsor

, , 

Verification Date

February 2017