Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Nasopharyngeal Carcinoma

Sponsor

First Affiliated Hospital of Guangxi Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT02237924

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A total of 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. They were randomly divided into two groups, with 60 patients in each group. One group was treated with intensity-modulated radiation therapy (IMRT) combined with Endostar and the other group was treated with IMRT combined with concurrent chemotherapy. The short term efficacy and the toxic and side effects of these treatments were evaluated. The 1-year, 3-year, 5-year overall survival and progression-free survival of patients were analyzed. Our data may provide an alternative option for the treatment of locally advanced low-risk nasopharyngeal carcinoma with high efficacy and low toxicity.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: endostar Drug: DDP Radiation: IMRT	Phase 2

Detailed Description

This study was a multicenter, open-label, randomized controlled clinical trial. A set of unified standards were used, including the clinical research program, inclusion criteria, exclusion criteria, chemoradiotherapy regimen and evaluation criteria. Nine medical centers participated in this study and 120 patients with pathologically confirmed locally advanced low-risk nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: IMRT combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy) and IMRT combined with concurrent chemotherapy group ( IMRT 70-74Gy, DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles). After treatment, follow-up was performed every 3 months. The treatment toxicity, local control rate, distant metastasis-free survival, overall survival, progression-free survival were observed and assessed.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Endostar Combined With Intensity-modulated Radiotherapy Compare With Chemoradiation for Locoregionally Advanced,Low-risk Nasopharyngeal Carcinoma.

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: endostar + IMRT	Drug: endostar Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy Radiation: IMRT IMRT:70-74Gy for 2-3 cycles
Active Comparator: DDP + IMRT	Drug: DDP DDP:100mg/m2 for 2-3 cycles Radiation: IMRT IMRT:70-74Gy for 2-3 cycles

Arm

Intervention/Treatment

Experimental: endostar + IMRT

Drug: endostar

Endostar 7.5mg / m2, 2 cycles of continuous intravenous pumping for ten days,and 2 cycles of maintenance therapy after radiotherapy

Radiation: IMRT

IMRT:70-74Gy for 2-3 cycles

Active Comparator: DDP + IMRT

Drug: DDP

DDP:100mg/m2 for 2-3 cycles

Radiation: IMRT

IMRT:70-74Gy for 2-3 cycles

Outcome Measures

Primary Outcome Measures

5-year Overall Survival [6 years]
The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ，including 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy，and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go to observation period for 5 years.

Secondary Outcome Measures

3-year Progression Free Survival [4 years]
The subjects were randomly divided into two groups. Group A: IMRT combined with Endostar ，including 2 cycles of continuous intravenous pumping, and 2 cycles of maintenance therapy after radiotherapy，and Group B: IMRT combined with concurrent chemotherapy for 2 or 3 cycles. After treatment, the subjects go into observation period. MRI will be used for evaluating the carcinoma status. During 3 years, any relapse or death will be recorded.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients of either gender and aged from 18 to 70 years old.
patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
patients at stage III/IVM0 by UICC2010 staging; patients with higher risk factors (such as N3 and T4N2-phase lymph node ≥4 cm) were excluded.
KPS ≥ 70 (Appendix I)
patients with available MRI data of nasopharynx and measurable tumor lesions.
patients did not receive any treatment before enrollment.
patients with expected survival longer than 6 months.
biochemical indexes: hemoglobin > 120 g/L, WBC > 4 x 109 /L, and blood platelet ≥ 100 x 109 /L; levels of indicators for hepatic and renal function was 1.25 folds of the upper limit of normal value.
the informed content was obtained from every patient.
patients with effective follow-up.

Exclusion Criteria:

those with malignant tumors other than nasopharyngeal carcinoma, stage I non-melanoma skin cancer, and cervical carcinoma in situ.
those received treatments before enrollment.
pregnant or lactating women and reproductive women without contraception.
those who were undergoing other drug trials.
those with severe complications, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, mental illness and uncontrollable diabetes.
those who could not be followed up at regular intervals.
those who were treated with tumor targeting drugs.
those who could not subject to MRI examination.
those who could not meet the requirements of the prescribed dose.
those with hemorrhagic tendency.