- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03058432
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
February 16, 2017 updated by: Zhejiang Cancer Hospital
Concurrent Chemotherapy for Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
To evaluate concurrent chemotherapy for elderly patients with locoregionally advanced nasopharyngeal carcinoma treated by intensity-modulated radiotherapy
Study Type
Interventional
Enrollment (Anticipated)
122
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Xiaozhong Chen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensity-modulated Radiotherapy
Radiotherapy alone was given.
|
|
Active Comparator: Concurrent chemoradiotherapy
Concurrent cisplatin-based radiotherapy was given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From date of treatment until the date of completing treatment 1 month later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
February 16, 2017
First Submitted That Met QC Criteria
February 16, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 16, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Pharyngeal Neoplasms
- Otorhinolaryngologic Neoplasms
- Head and Neck Neoplasms
- Nasopharyngeal Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Nasopharyngeal Neoplasms
- Carcinoma
- Nasopharyngeal Carcinoma
Other Study ID Numbers
- ZJCH-2016-HN03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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