The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Completed; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01187238

CH-HN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Arm1-radical radiotherapy alone group

No Intervention group

Description:

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

Arm2-concurrent chemoradiotherapy group

Experimental group

Description:

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.

Treatment:

Drug: cisplatin