Nasopharyngeal Carcinoma
Conditions
Keywords
Endostar, IMRT, recurrent, NPC
Brief 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.
Detailed description
Locally recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but severe late toxicities become the most common reason of death in IMRT salvaged NPC patients. The aim of this phase II randomized controlled study is to address the efficacy of concurrent Endostar (Endostatins) with IMRT to reduce the occurrence of severe late toxicities compared with IMRT alone for locally recurrent NPC patients.
Interventions
DRUGEndostatins
Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
RADIATIONIMRT
IMRT is to give GTV 60Gy in 27 fractions.
Sponsors
JiangXi Province Tumor Hospital
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
Second Affiliated Hospital of Nanchang University
First People's Hospital of Foshan
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
The Affiliated Ganzhou Hospital of Nanchang University
First Affiliated Hospital of Gannan Medical University
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with grade 4-5 late adverse events as assessed by RTOG/EORTC Late Radiation Morbidity Scoring Schema | From 3 months after the end of IMRT to 1 year after the end of IMRT |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with severe acute toxicities as assessed by CTCAE v3.0 | From the beginning of IMRT to 3 months after the end of IMRT |
| Overall survival | From the beginning the IMRT to 3 year after the end of IMRT |
Countries
China
Outcome results
None listed