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Comparison of 3-weekly administration of continuous dose cisplatin with divided dose in head and neck carcinoma

Phase 2
Conditions
Condition 1: Malignant neoplasm of base of tongue. Condition 2: Malignant neoplasm of other and unspecified parts of tongue. Condition 3: Malignant neoplasm of oropharynx. Condition 4: Malignant neoplasm of nasopharynx. Condition 5: Malignant neoplasm of hypopharynx. Condition 6: Malignant neoplasm of pyriform sinus. Condition 7: Malignant neoplasm of larynx.
Malignant neoplasm of base of tongue
Malignant neoplasm of other and unspecified parts of tongue
Malignant neoplasm of oropharynx
Malignant neoplasm of nasopharynx
Malignant neoplasm of hypopharynx
Malignant neoplasm of pyriform sinus
Malignant neoplasm of larynx
Registration Number
IRCT20201220049776N1
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Men and women under 70 years of age, known case of head and neck SCC with karnofsky performance status >= 70%
Definitive chemoradiation or adjuvant chemoradiation in patients with extranodal extension or positive margin
Radiation dose 66-70 Gy

Exclusion Criteria

History of chemotherapy
Kidney disease and Diabetes

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Mucositis. Timepoint: Weekly during radiation for 7 weeks. Method of measurement: Examination.;Disphasia. Timepoint: Weekly during radiation for 7 weeks. Method of measurement: Examination.;Cytopenia. Timepoint: Weekly during radiation for 7 weeks. Method of measurement: Laboratory data.
Secondary Outcome Measures
NameTimeMethod
Disease free survival. Timepoint: 18 months. Method of measurement: Phone calls. Visit at the Office.;Overall survival. Timepoint: 18 months. Method of measurement: Phone calls. Visit at the Office.
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