Overview
Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
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).
Eligibility
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)