Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Radiotherapy, Endostatin, Capecitabine
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).
Interventions
DRUGEndostatin and Capecitabine
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)
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Radiotherapy Combined With Endostatin and Capecitabine
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence free survival (RFS) | 3 years | calculated from the date of randomisation to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 5 years | calculated from date of randomisation to death |
| distant metastasis-free survival (DMFS) | 3 years | calculated from date of randomisation to the first distant failure |
| Local-regional free survival (LRFS) | 3 years | calculated from date of randomisation to the first Local-regional failure |
| adverse events (AEs) and severe adverse events (SAE) | 5 years | graded according to NCI CTCAE v5.0 |
| quality of life (QoL) | 3 years | the change of QoL from randomization to 12 months after chemoradiation, graded according to EORTC QLQ-C30 V3.0 |
Countries
China
Contacts
Primary ContactTing Jin, MD
Outcome results
None listed