Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

Sponsor

First Affiliated Hospital of Guangxi Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02907710

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

8.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A total of 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. Patients were randomly divided into two groups, with 150 patients in each group. One group was treated with Concurrent Chemoradiotherapy combined with Endostar and the other group was treated with Concurrent Chemoradiotherapy. 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. The investigators data may provide an alternative option for the treatment of Locoregionally advanced nasopharyngeal carcinoma with high efficacy and low toxicity.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Endostar Drug: DDP	Phase 3

Detailed Description

This study was a multicenter, prospective, 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. Five medical centers participated in this study and 300 patients with pathologically confirmed Locoregionally advanced nasopharyngeal carcinoma were enrolled. These patients were stratified according to clinical stage and participating center, and were randomly divided into two groups: concurrent chemoradiotherapy combined with Endostar group ( IMRT 70-74Gy, Endostar 7.5mg / m2, 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy) and concurrent chemoradiotherapy 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

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter, Prospective, Randomized Controlled Clinical Trial Comparing Endostar With Concurrent Chemoradiotherapy and Concurrent Chemoradiotherapy in the Treatment of Locoregionally Advanced Nasopharyngeal Carcinoma (NPC)

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2018

Anticipated Study Completion Date :

Nov 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: concurrent chemoradiotherapy + endostar Drug: Endostar Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy	Drug: Endostar intravenous infusion Other Names: recombinant human endostatin Drug: DDP
Active Comparator: concurrent chemoradiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy	Drug: DDP

Arm

Intervention/Treatment

Experimental: concurrent chemoradiotherapy + endostar

Drug: Endostar Endostar 7.5mg / m2,3 cycles of intravenous infusion for ten days, and 2 cycles of maintenance therapy after radiotherapy Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy

Drug: Endostar

intravenous infusion

Other Names:

recombinant human endostatin

Drug: DDP

Active Comparator: concurrent chemoradiotherapy

Drug: DDP DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles Radiation: IMRT IMRT:70-74Gy

Drug: DDP

Outcome Measures

Primary Outcome Measures

3-year Progression Free Survival [3 years]
The subjects were randomly divided into two groups. Group A: concurrent chemoradiotherapy combined with Endostar，including 3 cycles of intravenous infusion, and 2 cycles of maintenance therapy after radiotherapy，and Group B: concurrent chemoradiotherapy, 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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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/IVb by UICC2010 staging.
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.