Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether concurrent chemotherapy and IMRT is effective in the treatment of locally stage T3/T4 recurrent nasopharyngeal carcinoma patients compared with IMRT alone.

Detailed Description
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Locally T3/T4 recurrent nasopharyngeal carcinoma (NPC) may be salvaged by intensity modulated-radiotherapy (IMRT), but local control is not good enough and late toxicities is usually severe The aim of this phase III randomized controlled study is to address the efficacy of concurrent chemotherapy (cisplatin) with IMRT to improve local control and lower the occurrence of severe late toxicities compared with IMRT alone for locally T3/T4 recurrent NPC patients.

Official Title
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Intensity-modulated Radiotherapy Plus Concurrent Chemotherapy Versus Intensity-modulated Radiotherapy Alone In Patients With rT3/T4 Locally Advanced Recurrent Nasopharyngeal Carcinoma: A Phase 3 Multicenter Prospective Randomised Controlled Trial (IMRT)

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Cisplatin
* Radiation: IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Pathologically or clinically confirmed rT3/T4 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: 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 cisplatin<br>IMRT and concurrent cisplatin to treat T3/T4 locally recurrent NPC patients. Cisplatin 100mg/M2 is to give D1,D22 of IMRT for 2 cycles. IMRT is to give GTV 60Gy in 27 fraction | Drug: Cisplatin<br>* cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction<br>Radiation: IMRT<br>* Radiation: IMRT IMRT is to give 60Gy in 27 fraction<br>|
| Experimental: IMRT alone<br>IMRT alone to treat T3/T4 locally recurrent NPC patients. IMRT is to give 60Gy in 27 fraction | Radiation: IMRT<br>* Radiation: IMRT IMRT is to give 60Gy in 27 fraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | From the beginning the IMRT to 3 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 | 
| 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 | 

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