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The Value of Concurrent Chemoradiotherapy for Stage II Nasopharyngeal Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Gao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01187238
First received: August 18, 2010
Last updated: September 9, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • Acute toxicities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Acute toxicity will be measured by CTCAE3.0


Secondary Outcome Measures:
  • Long term treatment results [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 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
Study First Received: August 18, 2010
Last Updated: September 9, 2014
Health Authority: China: Ministry of Health

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

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Neoplasms
Pharyngeal Neoplasms
Carcinoma
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014