The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

Phase 2

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: cisplatin

• Registration Number: NCT01187238
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to verify the role of adding cisplatin chemotherapy to the intensity-modulated radiotherapy (IMRT) for stage II nasopharyngeal carcinoma.

Detailed Description

Clinical Stage II nasopharyngeal carcinoma consisted of T2N0M0, T1N1M0, T2N1M0 three subgroups, the data came from conventional radiotherapy era showed that the prognosis of this three subgroups were different, the N1 groups suffered more distant metastasis than N0 group, and some literature showed that combined chemotherapy with radiotherapy in stage II patients can improve the treatment results.

Intensity-modulated radiotherapy (IMRT)now is an widely used technique in the treatment of nasopharyngeal carcinoma, the preliminary results showed that IMRT can improve the quality of life in nasopharyngeal through salivary gland preservation.

Compared IMRT alone with IMRT plus cisplatin concurrent chemotherapy in the treatment of stageII nasopharyngeal carcinoma, we hope to confirm whether stage II (and which subgroup) nasopharyngeal carcinoma will be benefit from concurrent chemoradiotherapy.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-08-18
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Primary Completion: 2012-07
• Study Completion: 2017-10
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-14
• Last Update Posted: 2020-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• pathological confirmed squamous cell carcinoma, WHO II-III type,
• clinical stage II (UICC 7th edition, 2009)
• Karnovsky performance score > 70
• first course of radiotherapy, without radiotherapy and chemotherapy history for other head and neck cancer.
• anticipated life span more than 6 month
• Hemoglobin > 120g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L
• liver and renal function under the 1.25 normal upper limit
• with written consent information

Exclusion Criteria

• have other cancer history
• have chemotherapy history
• have radiotherapy history
• have head and neck surgery history(exclusion lymph node biopsy)
• evidence showed distant metastasis or other cancer
• other severe medical comorbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm2-concurrent chemoradiotherapy group	cisplatin	Arm2-concurrent chemoradiotherapy group, the eligibility patients will received radiotherapy the same as radical radiotherapy arm,and also will received the concurrent chemotherapy wiht the regimen consist of cisplatin 40mg/m2, weekly for 7weeks.

Primary Outcome Measures

Name	Time	Method
Acute toxicities	2 years	Acute toxicity will be measured by CTCAE3.0

Secondary Outcome Measures

Name	Time	Method
Long term treatment results	5 years	1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.

Trial Locations

Locations (3)

Zhejiang province cancer hospital; 🇨🇳 Hangzhou, Zhejiang, China

Cancer hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Cancer hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China