Clinical Trial: A Trial of Endostar in Patients With Carcinoma of the Head and Neck

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of recombinant human endostatin（continuously-pumped）combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck. The patients will be randomized to concurrent radiotherapy (CRT) arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT.

Detailed Summary:

The patients will be randomized to CRT arm and CRT + Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT. Treatment cycles will be repeated every 21 days for a maximum of 4 cycles. In CRT + Endostar arm, Endostar will be continuously intravenous pumped (7.5 mg/m2) for 14 days (d1-d14) during chemotherapy and for 5 days/week (d-5-d-1, d3-d7, d10-d14, d17-d21) during IMRT.

Prior to enrollment in this study and while the patient is receiving the therapy, routine tests, ECG, head and neck CT scan and MRI will be performed to check the body's response to the treatment. Further more, before and after the treatment, the circulating endothelial cells (CECs), endothelial progenitor cells (CEPs), vascular endothelial growth factor (VEGF), Cancer embryo antigen (CEA), Neuron-specific enolase (NSE) in blood and Microvessel density (MVD), hypoxia-inducible factor-1a (HIF-1a), P53, VEGF, Survivin in pathological specimens will be tested.

Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 4 cycles.

Primary outcome: The response rate (RR), the clinical benefit rate (CBR), time of tumor progression (TTP).

Secondary outcomes: The quality of life (QOL)，Safety and Tolerability.

Sponsor: China International Medical Foundation

Current Primary Outcome: Progression-Free Survival (Mon); PFS, According to RECIST v1.1 [ Time Frame: up to 40 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of life (QOL); Scores range from 0 to 5 [ Time Frame: up to 40 months ]

Original Secondary Outcome: Same as current

Information By: China International Medical Foundation

Dates:
Date Received: August 12, 2016
Date Started: June 2016
Date Completion: December 2018
Last Updated: March 28, 2017
Last Verified: March 2017