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Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

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ClinicalTrials.gov Identifier: NCT03058432
Recruitment Status : Unknown
Verified February 2017 by Zhejiang Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : February 23, 2017
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Zhejiang Cancer Hospital

Study Description
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Brief Summary:
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Radiation: Radiotherapy alone Radiation: Concurrent chemoradiotherapy Phase 2

Detailed Description:
To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Concurrent cisplatin based chemoradiotherapy versus radiotherapy alone
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Intensity-modulated Radiotherapy
Radiotherapy alone was given.
 Radiation: Radiotherapy alone
Active Comparator: Concurrent chemoradiotherapy
Concurrent cisplatin-based radiotherapy was given.
 Radiation: Concurrent chemoradiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. therapeutic success [ Time Frame: From date of treatment until the date of completing treatment 1 month later ]
    A combined primary end point, named "therapeutic success"(TS), was used; it took into account activity, toxicity, and compliance.A TS was defined as a patient completing radiotherapy at the planned dose and schedule (no re-treatment delays beyond 2 weeks), and having an objective response (either complete or partial based on RECIST criteria) without (1) grade 3-4 nonhematological toxicity, (2) complications associated with hematologic toxicity such as febrile neutropenia, infection, bleeding, or transfusion, or (3) any toxicity leading to hospitalization or death.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma

Exclusion Criteria:

  • A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions,supposed to live less than 6 months.
Contacts and Locations
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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): NCT03058432


Locations
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China, Zhejiang
Xiaozhong Chen Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Xiaozhong Chen, MD    +86-571-88128202    cxzfyun@sina.com   
Sponsors and Collaborators
Zhejiang Cancer Hospital
More Information
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Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03058432    
Other Study ID Numbers: ZJCH-2016-HN03
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
 Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases