Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).

Detailed Description
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In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).

Official Title
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Induction Chemotherapy With Docetaxel and Cisplatin Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

Conditions
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Locally Advanced Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Radiation: IMRT/TOMO
* Drug: Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system) No evidence of distant metastasis (M0) Performance status: KPS>70 With normal liver function test (ALT, AST <1.5ULN) Renal: creatinine clearance >60ml/min Without hematopathy,marrow: WBC >4*109/L, HGB>80G/L, and PLT>100*109/L. With controlled blood glucose for diabetes patients Written informed consent satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) Exclusion Criteria: WHO type I squamous cell carcinoma or adenocarcinoma Age >65 or <18 With a history of renal disease Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Peripheral neuropathy Emotional disturbance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: IC+RT group<br>3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy. | Drug: Docetaxel<br>* 3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.<br>* Other names: DOC;Drug: Cisplatin<br>* 3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.<br>* Other names: DDP;Radiation: IMRT/TOMO<br>* intensity modulated radiation therapy or tomotherapy<br>|
| Active Comparator: IC+CCRT group<br>3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2. | Drug: Docetaxel<br>* 3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.<br>* Other names: DOC;Drug: Cisplatin<br>* 3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.<br>* Other names: DDP;Radiation: IMRT/TOMO<br>* intensity modulated radiation therapy or tomotherapy<br>Drug: Chemotherapy<br>* 2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.<br>* Other names: concurrent chemotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress Free Survival (PFS) | PFS means assignment to the date of any local or distant progress of the disease. | 3 years after the inception assignment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | The overall survival denote to assignment to date of death from any cause. | 3 years and 5 years after the inception of the assignment | 
| Adverse Events | Observe and record the toxicity profile (including but not limit to mucositis, liver and kidney function, et al.) according NCI-CTCAE (3rd edition) during the neoadjuvant chemotherapy, chemoradiation and follow-up. | Participants will be followed for the duration of hospital stay, an expected average of 100 days and every 3 months thereafter for 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nasopharyngeal carcinoma, Induction chemotherapy, radiotherapy, chemoradiotherapy