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

NCT ID: NCT04220528

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 129 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2023-12-01

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radical chemoradiotherapy plus oral capecitabine/teggiol

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.

Group Type: EXPERIMENTAL

Capecitabine/Tiggio

Intervention Type: DRUG

Drug: Capecitabine/Tiggio

Radical chemoradiotherapy：Induction chemotherapy plus Concurrent chemoradiotherapy

Induction chemotherapy：Gemcitabine (1000mg/m2) D1 D8+ nida platinum (80mg/m2) D2 q3w ×3cycle

Concurrent chemoradiotherapy：IMRT was used for radiotherapy, during which D1 and D22 were given two cycles of single drug concurrent chemotherapy with nidapatin (100mg/m2).

Interventions

Capecitabine/Tiggio

Drug: Capecitabine/Tiggio

Radical chemoradiotherapy：Induction chemotherapy plus Concurrent chemoradiotherapy

Induction chemotherapy：Gemcitabine (1000mg/m2) D1 D8+ nida platinum (80mg/m2) D2 q3w ×3cycle

Concurrent chemoradiotherapy：IMRT was used for radiotherapy, during which D1 and D22 were given two cycles of single drug concurrent chemotherapy with nidapatin (100mg/m2).

Intervention Type: DRUG

Other Intervention Names

Radiation

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shaojun Lin, DR

Role: CONTACT

linshaojun@yeah.net

13860603879

Jingfeng Zong, DR

Role: CONTACT

zongjingfeng@126.com

13365910013

Facility Contacts

Shaojun Lin, doctor

Role: primary

linshaojun@yeah.com

0591-62752225

Other Identifiers

NPC002.1

Identifier Type: -

Identifier Source: org_study_id