Endostar for Locally Recurrent Nasopharyngeal Carcinoma
- Registration Number
- NCT02636231
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 96
- Pathologically or clinically confirmed locally recurrent nasopharyngeal carcinoma;
- No evidence of distant metastasis
- More than 1 year from the end of the first course of radiotherapy
- Male, or female not in the phase of lactating or pregnancy
- ECOG 0-2
- Aged 18-70 years old
- WBC count ≥4×109/L, neutrophile granulocyte count≥1.5×109/L, PLT count ≥100×109/L, Hb ≥9g/L
- Total bilirubin, AST, ALT≤2.0 times of upper normal limits; creatinine ≤1.5 times of upper normal limits
- Written informed consort signed
- Only regionally recurrence
- Evidence of distant metastasis
- Prior invasive malignancy; noninvasive cancers (For example, carcinoma in situ of the bladder, oral cavity, or cervix are all permissible) are permitted
- Severe, active co-morbidity
- Prior anti-tumor treatment after diagnosis of local recurrence
- MRI was not performed 3 months after the first course of radiotherapy
- Abnormal function of heart, brain and lungs, etc
- Lactation or pregnancy
- Severe nasopharyngeal mucosal necrosis at the diagnosis of local recurrence
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMRT and concurrent Endostar Endostatins IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. IMRT is to give GTV 60Gy in 27 fractions. IMRT and concurrent Endostar IMRT IMRT and concurrent Endostar (Endostatins) to treat locally recurrent NPC patients; Endostar is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles. IMRT is to give GTV 60Gy in 27 fractions. IMRT alone IMRT IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
Cancer Center of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Gannan Medical University
🇨🇳GanZhou, Jiangxi, China
The First Affiliated Hospital of Clinical Medicine of G.D.P.U.
🇨🇳Guangzhou, Guangdong, China
The Affiliated GanZhou Hospital of NanChang University
🇨🇳Ganzhou, Jiangxi, China
Second Affiliated Hospital of Nanchang University
🇨🇳NanChang, Jiangxi, China
JiangXi Province Tumor Hospital
🇨🇳NanChang, Jiangxi, China
First People's Hospital of Foshan
🇨🇳Foshan, Guangdong, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China