Endostar for Locally Recurrent Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Randomized Controlled Study to Compare Endostar and IMRT vs. IMRT Alone for Locally Recurrent Nasopharyngeal Carcinoma Patients

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Endostatins
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IMRT and concurrent Endostar<br>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. | Drug: Endostatins<br>* Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.<br>* Other names: Endostar;Radiation: IMRT<br>* IMRT is to give GTV 60Gy in 27 fractions.<br>|
| Experimental: IMRT alone<br>IMRT alone to treat locally recurrent NPC patients. IMRT is to give GTV 60Gy in 27 fractions. | Radiation: IMRT<br>* IMRT is to give GTV 60Gy in 27 fractions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endostar, IMRT, recurrent, NPC