Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

Brief Title

Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

Official Title

Single Arm, Open, Multicenter Phase II Clinical Study of Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

Brief Summary

      This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the
      efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in
      patients with N3.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Progression-Free Survival(PFS)

Condition

Nasopharyngeal Carcinoma

Intervention

Capecitabine/Tiggio

Study Arms / Comparison Groups

 Radical chemoradiotherapy plus oral capecitabine/teggiol

Description:  Patients with newly diagnosed, non-metastatic stage N3 NPC was given Teggio 40-60mg bid d1-14, q4w, oral maintenance chemotherapy for 1 year or capecitabine 2500mg/m2/d twice daily oral d1-14, q4w after receiving radical chemoradiotherapy.

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

Drug

Estimated Enrollment

Start Date

December 1, 2019

Completion Date

December 1, 2023

Primary Completion Date

June 1, 2023

Eligibility Criteria

        Inclusion Criteria:

          1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was
             nasopharyngeal carcinoma;

          2. No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according
             to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T
             and N3M0 stage nasopharyngeal carcinoma).

          3. Aged 18-65;

          4. At least one measurable tumor lesion;

          5. PS (ECOG standard) 0-1;

          6. Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L;

          7. Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value
             (ULN), total bilirubin < 1.5×ULN;Serum creatinine < 1.5×ULN;

          8. Expected survival period ≥6 months;

          9. Signing informed consent;

         10. Follow up regularly and comply with test requirements.

        Exclusion Criteria:

          1. Patients with distant organ metastasis;

          2. Recurrent nasopharyngeal carcinoma;

          3. Creatinine clearance rate <60ml/ min;

          4. Have received chemotherapy, radiotherapy or targeted therapy;

          5. Have or are suffering from other malignant tumors within 5 years (except non-melanoma
             skin cancer or pre-invasive cervical cancer);

          6. Serious complications, such as uncontrolled hypertension, coronary heart disease,
             diabetes, heart failure, etc.

          7. Active systemic infection;

          8. History of serious lung or heart disease;

          9. Drug or alcohol abuse;

         10. No or limited capacity for civil conduct;

         11. The patient has a physical or mental disorder, and the researcher considers that the
             patient is unable to fully or fully understand the possible complications of this
             study;

         12. Receive chronic systemic immunotherapy or hormone therapy outside the study;

         13. Pregnancy or lactation period;

         14. Patients receive blind treatment in other clinical studies.

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 13860603879, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04220528

Organization ID

NPC002.1

Responsible Party

Sponsor

Study Sponsor

Fujian Cancer Hospital

Collaborators

 Jiangxi Provincial Cancer Hospital

Study Sponsor

, ,

Verification Date

November 2019