The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2017-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm1-radical radiotherapy alone group

Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Arm2-concurrent chemoradiotherapy group

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.

Group Type EXPERIMENTAL

cisplatin

Intervention Type DRUG

in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7

Interventions

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cisplatin

in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7

Intervention Type DRUG

Other Intervention Names

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DDP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No