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

NCT04220528 | Unknown Phase 2

• 1 other identifier: NPC002.1
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Radical chemoradiotherapy plus oral capecitabine/teggiol

EXPERIMENTAL

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.

Drug: Capecitabine/Tiggio

Interventions

Capecitabine/Tiggio 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).

Also known as: Radiation

Radical chemoradiotherapy plus oral capecitabine/teggiol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
• 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).
• Aged 18-65;
• At least one measurable tumor lesion;
• PS (ECOG standard) 0-1;
• Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L;
• 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;
• Expected survival period ≥6 months;
• Signing informed consent;
• Follow up regularly and comply with test requirements.

You may not qualify if:

• Patients with distant organ metastasis;
• Recurrent nasopharyngeal carcinoma;
• Creatinine clearance rate \<60ml/ min;
• Have received chemotherapy, radiotherapy or targeted therapy;
• Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);
• Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.
• Active systemic infection;
• History of serious lung or heart disease;
• Drug or alcohol abuse;
• No or limited capacity for civil conduct;
• 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;
• Receive chronic systemic immunotherapy or hormone therapy outside the study;
• Pregnancy or lactation period;
• Patients receive blind treatment in other clinical studies.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead
• Jiangxi Provincial Cancer Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator

Study Sites (1)

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, 350014, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Capecitabine; Radiation

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Physical Phenomena

Central Study Contacts

Shaojun Lin, DR

CONTACT

13860603879; linshaojun@yeah.net

Jingfeng Zong, DR

CONTACT

13365910013; zongjingfeng@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 7, 2020
• Study Start: December 1, 2019
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 7, 2020

Record last verified: 2019-11

Locations

CN (1)