Radiotherapy combined with recombinant human endostatin and capecitabine for patients with nasopharyngeal carcinoma (NPC) resistant to induction chemotherapy.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
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)
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGthe First Hospital of Jiaxing
Jiaxing, Zhejiang, China
RECRUITINGJinhua Central Hospital
Jinhua, Zhejiang, China
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
Time frame: 3 years
overall survival (OS)
calculated from date of randomisation to death
Time frame: 5 years
distant metastasis-free survival (DMFS)
calculated from date of randomisation to the first distant failure
Time frame: 3 years
Local-regional free survival (LRFS)
calculated from date of randomisation to the first Local-regional failure
Time frame: 3 years
adverse events (AEs) and severe adverse events (SAE)
graded according to NCI CTCAE v5.0
Time frame: 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
Time frame: 3 years
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The Central Hospital of Lishui City
Lishui, Zhejiang, China
RECRUITINGNingbo First Hospital
Ningbo, Zhejiang, China
RECRUITINGNingbo Medical Center Lihuili Eastern Hospital
Ningbo, Zhejiang, China
RECRUITINGPeople's Hospital of Quzhou
Quzhou, Zhejiang, China
RECRUITING