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Phase III randomized clinical trial of elective neck irradiation in oropharyngeal squamous cell cancer: Is high dose necessary?

Phase 3
Recruiting
Conditions
Oropharyngeal squamous cell cancer
Registration Number
TCTR20180203001
Lead Sponsor
Faculty of Medicine, Chulalongkorn University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
180
Inclusion Criteria

-Stage I-IVB oropharyngeal cancer
-Adequate performance status
-Anticipated to the informed consent

Exclusion Criteria

-Evidence of distant metastasis
-Recurrent oropharyngeal cancer
-Undergone surgery upon primary tumor or neck apart from incisional or excisional biopsy
-Previous irradiation for head neck tumor
-Prior chemotherapy to study entry
-History of malignancy other than non-melanoma skin cancer which is controlled at least 5 years

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ocoregional control 2 years Rate of recurrence in elective neck area
Secondary Outcome Measures
NameTimeMethod
Acute toxicities During radiation treatment CTCAE 4.03,Late toxicities 2 years CTCAE 4.03
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