Radiotherapy Combined With Endostatin and Capecitabine for NPC

Study Overview
=================
Brief Summary
-----------------
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.

Detailed Description
-----------------
This study was a single-arm, open-label, phase II study of radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy. fourty-one patients of locally advanced NPC resistant to induction chemotherapy were enrolled. Patients received radiotherapy combined with recombinant human endostatin and capecitabine. The primary endpoint was Recurrence free survival (RFS). Secondary goals included overall survival (OS), distant metastasis-free survival (DMFS), Local-regional free survival (LRFS); adverse events (AEs) and severe adverse events (SAE); safety and quality of life (QoL).

Official Title
-----------------
Radiotherapy Combined With Recombinant Human Endostatin and Capecitabine for Patients With Nasopharyngeal Carcinoma Resistant to Induction Chemotherapy

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Endostatin and Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type). Tumor staged as T3-4N1/N2-3 (according to the 8th American Joint Commission on Cancer edition). No evidence of distant metastasis (M0). Satisfactory performance status: Karnofsky scale (KPS) > 70. Adequate marrow: leucocyte count ≥4000/μL, hemoglobin ≥90g/L and platelet count ≥100000/μL. Normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN. Adequate renal function: creatinine clearance ≥60 ml/min. Patients must be informed of the investigational nature of this study and give written informed consent. unsatisfactory tumor response (stable or progressive disease) after neoadjuvant chemotherapy (NACT) Exclusion Criteria: WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. Treatment with palliative intent. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Radiotherapy Combined With Endostatin and Capecitabine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endostatin and Capecitabine<br>Patients received radiotherapy Combined With Endostatin and Capecitabine | Drug: Endostatin and Capecitabine<br>* Patients received radiotherapy Combined With Endostatin(37.5mg/m2, continuous intravenous infusion for 120h, D-7, D8, D22, D36) and Capecitabine( 650 mg/m2 bid, orally, d1-21, every 3 weeks as a cycle for 17 cycles)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival (RFS) | calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | calculated from date of randomisation to death | 5 years | 
| distant metastasis-free survival (DMFS) | calculated from date of randomisation to the first distant failure | 3 years | 
| Local-regional free survival (LRFS) | calculated from date of randomisation to the first Local-regional failure | 3 years | 
| adverse events (AEs) and severe adverse events (SAE) | graded according to NCI CTCAE v5.0 | 5 years | 
| quality of life (QoL) | the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0 | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nasopharyngeal Carcinoma, Radiotherapy, Endostatin, Capecitabine