A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal Carcinoma

NCT02444949 | Completed Phase 2

• 1 other identifier: CTGU001
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

Among all the head and neck tumors, nasopharyngeal carcinoma (NPC) has a high tendency of recurrence and metastasis. For the advanced NPC patients, chemoradiotherapy is the main way of treatment. Currently, chemotherapy with cisplatin (DDP) combines with 5-fluorouracil (5-FU) is the classic front line therapy for NPC. However, the abnormal richness of angiogenesis of tumor and blood supply in tissue caused by radiation therapy often decrease the effects of radiochemotherapy. Human recombinant vascular endothelial inhibitor (endostar) can improve the sensitivity to chemoradiation via selectively inhibiting the migration of endothelial cells and the formation of tumor vessels. Moreover, it would induce vascular remodeling and normalization of the tumor vasculature, which will effectively aid the delivery of oxygen and anticancer drugs. In sum, antiangiogenesis in combination with chemoradiotherapy will be a promising way of treatment for NPC. In this study, the first-treated patients with NPC (stage Ⅲ or Ⅳa) confirmed by pathology, and patients with recurrent and metastatic NPC will be randomly assigned to two groups (1:1): a trial group (DDP, 5-FU, endostar and sequential intensity modulated radiation therapy (IMRT)), and a control group (DDP，5-FU and sequential IMRT). Evaluations will be developed including progression-free survival (PFS), Overall response rate（ORR）, overall survival (OS), adverse effects rate and quality of life. This research will provide more evidences of evidence-based medicine for the safety and tolerability of endostar and the clinical application of endostar in NPC treatment.

Conditions

Nasopharyngeal Neoplasms

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival

  Patients will be followed from the day in which patients are enrolled the clinical trial and end up one year later, during the one year the patients will be observed whether they have disease progress or die from any cause.

• Overall response rate

  After the second periodicity chemotherapy, an expected average of 12 weeks, the rate of patients with complete response and partial response accounted for the total number of assessable cases .

Secondary Outcomes (3)

• Adverse effects as assessed by adverse events

  It is the time from the start of treatment to 20 weeks

• Overall survival

  Patients will be followed from the day in which patients are enrolled the clinical trial and end up two years later, during the two years the patients will be observed whether they die from any cause.

• Quality of Life measured by the ECDG score

  Firstly, Patients will be assessed before the start of periodicity treatment, then they will be assessed 20 weeks and 24 weeks after the treatment.

Study Arms (2)

endostar+DF+IMRT

EXPERIMENTAL

patient first receive one periodicity chemotherapy(DDP (25mg/m2/d; ivgtt; d1～3)+5-FU (600mg/m2/d; ivgtt; d1～5)+endostar (150mg/5d; civ; d1～5)), then given IMRT (5 times per week, 6 weeks). After rest 4 weeks, continue to give the chemotherapy (21 days for a periodicity, 3 periodicities).

Drug: endostar; Radiation: intensity modulated radiation; Drug: cisplatin

DF+IMRT

OTHER

patient first receive one periodicity chemotherapy(DDP (25mg/m2/d; ivgtt; d1～3)+5-FU (600mg/m2/d; ivgtt; d1～5)), then given IMRT (5 times per week, 6 weeks). After rest 4 weeks, continue to give the chemotherapy (21 days for a periodicity, 3 periodicities).

Radiation: intensity modulated radiation; Drug: cisplatin

Interventions

endostar DRUG

Also known as: Human recombinant vascular endothelial inhibitor

endostar+DF+IMRT

intensity modulated radiation RADIATION

DF+IMRT; endostar+DF+IMRT

cisplatin DRUG

Also known as: DDP

DF+IMRT; endostar+DF+IMRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 70 ears ;
• Eastern Cooperative Oncology Group performance status of 0-1;
• diagnosed with first-treated NPC (Ⅲ/Ⅳa stage) confirmed by pathology;
• ecurrent and metastatic NPC with indication of chemoradiotherapy;
• one measurable lesion at least (according to the RECIST guidelines, the lesion iameter≥20 mm with MRI);
• life expectancy of ≥ 12 weeks;
• adequate hematologic, renal, cardiac and liver function;
• hemameba≥4.0×109/L;
• neutrophil≥2.0×109/L;
• platelet≥100×109/L;
• hemoglobin≥95g/L;
• Serum bilirubin, ALT and AST ≤1.5 times of maximum criteria;
• sufficiently understand this study situation and signed the informed consent.

You may not qualify if:

• allergy or intolerance to study drugs;
• receiving other anti-cancer therapy;
• uncontrolled central nervous system lesions;
• dysfunction of important organs；
• history of cardiovascular disease(including congestive heart-failure, uncontrolled arrhythmia, angina pectoris which require long-term drug treatment, lular heart disease, myocardial infarction and resistant hypertension);
• pregnancy or lactation in women;
• protracted Infective wound;
• history of mental illness which is not easy controlled.

Sponsors & Collaborators

• China Three Gorges University, Yichang, China: lead

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

endostar protein; Cisplatin

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The section chief of Oncology Department, The First College of Clinical Medical Science, China Three Gorges University

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: May 15, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2019
• Last Updated: June 24, 2020

Record last verified: 2020-06