Endostar Combined With Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT02907710

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2019-11-30

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.

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Endostar

Intervention Type: DRUG

intravenous infusion

DDP

Intervention Type: DRUG

concurrent chemoradiotherapy

Drug: DDP

DDP 100mg / m2, intravenous infusion over 2 hours , for 2-3 cycles

Radiation: IMRT

IMRT:70-74Gy

Group Type: ACTIVE_COMPARATOR

DDP

Intervention Type: DRUG

Interventions

Endostar

intravenous infusion

Intervention Type: DRUG

DDP

Intervention Type: DRUG

Other Intervention Names

recombinant human endostatin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

min kang

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sheng ren wang, doctor

Role: STUDY_CHAIR

First Affiliated Hospital of Guangxi Medical University

Locations

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Countries

China

Central Contacts

min kang, doctor

Role: CONTACT

km1019@163.com

0086-0771-5356509

Facility Contacts

sheng ren wang, doctor

Role: primary

13807806008@163.com

0086-13807806008

min kang, doctor

Role: backup

km1019@163.com

0086-15977724416

References

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Reference Type: RESULT

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Other Identifiers

FirstGuangxiMU

Identifier Type: -

Identifier Source: org_study_id