Overview

Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine whether endostar and IMRT is effective in the treatment of locally recurrent nasopharyngeal carcinoma patients compared with IMRT alone.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Cancer Center of Guangzhou Medical University
First People's Hospital of Foshan
JiangXi Province Tumor Hospital
Second Affiliated Hospital of Nanchang University
The Affiliated Ganzhou Hospital of Nanchang University
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
The First Hospital of Gannan Medical University
Treatments:
Endostatins
Criteria
Inclusion Criteria:

1. Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;

2. No evidence of distant metastasis

3. More than 1 year from the end of the first course of radiotherapy

4. Male, or female not in the phase of lactating or pregnancy

5. ECOG 0-2

6. Aged 18-70 years old

7. WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb
≥9g/L

8. Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of
upper normal limits

9. Written informed consort signed

Exclusion Criteria:

1. Only regionally recurrence

2. Evidence of distant metastasis

3. Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the
bladder, oral cavity, or cervix are all permissible) are permitted

4. Severe, active co-morbidity

5. Prior anti-tumor treatment after diagnosis of local recurrence

6. MRI was not performed 3 months after the first course of radiotherapy

7. Abnormal function of heart, brain and lungs, etc

8. Lactation or pregnancy

9. Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence