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The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01187238
First Posted: August 24, 2010
Last Update Posted: September 10, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Li Gao, Chinese Academy of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Nasopharyngeal Carcinoma Drug: cisplatin Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Phase II Study of Intensity-modulated Radiotherapy Combined With Chemotherapy Versus Intensity-modulated Radiotherapy Alone for Stage II Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by Li Gao, Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Acute toxicities [ Time Frame: 2 years ]
    Acute toxicity will be measured by CTCAE3.0


Secondary Outcome Measures:
  • Long term treatment results [ Time Frame: 5 years ]
    1-, 3-year local-regional control, overall survival, disease-free survival, distant metastasis-free survival will be observed.


Enrollment: 86
Study Start Date: July 2010
Study Completion Date: August 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm1-radical radiotherapy alone group
Arm1-radical radiotherapy alone group, the eligibility patients will received radical intensity-modulated radiotherapy alone
Experimental: 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.
Drug: 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
Other Name: DDP

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187238


Locations
China, Guangdong
Cancer hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
China, Zhejiang
Zhejiang province cancer hospital
Hangzhou, Zhejiang, China, 310022
China
Cancer hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Li Gao, MD Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  More Information

Publications:
Responsible Party: Li Gao, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01187238     History of Changes
Other Study ID Numbers: CH-HN-001
First Submitted: August 18, 2010
First Posted: August 24, 2010
Last Update Posted: September 10, 2014
Last Verified: September 2014

Keywords provided by Li Gao, Chinese Academy of Medical Sciences:
Nasopharyngeal carcinoma
Stage II
Intensity-modulated radiotherapy
Concurrent chemoradiotherapy
Cisplatin

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Cisplatin
Antineoplastic Agents