Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

September 15, 2016 updated by: min kang, First Affiliated Hospital of Guangxi Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • The First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. patients of either gender and aged from 18 to 70 years old.
  2. patients with histologically confirmed non-keratinizing squamous cell nasopharyngeal carcinoma.
  3. patients at stage III/IVb by UICC2010 staging.
  4. KPS ≥ 70 (Appendix I)
  5. patients with available MRI data of nasopharynx and measurable tumor lesions.
  6. patients did not receive any treatment before enrollment.
  7. patients with expected survival longer than 6 months.
  8. 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.
  9. the informed content was obtained from every patient.
  10. patients with effective follow-up.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year Progression Free Survival
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year Overall Survival
Time Frame: 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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Investigators

  • Study Chair: sheng ren wang, doctor, First Affiliated Hospital of Guangxi Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 15, 2016

First Posted (ESTIMATE)

September 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstGuangxiMU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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