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

Nasopharyngeal Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220528
• Other study ID #: NPC002.1
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: November 2019
• Source: Fujian Cancer Hospital
• Contact: Shaojun Lin, DR
• Phone: 13860603879
• Email: linshaojun[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 129
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
China	Department of radiation oncology, Fujian cancer hospital	Fuzhou	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Fujian Cancer Hospital	Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival(PFS)	PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.	24 months