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

Complication assessment of concurrent chemoradiotherapy with 100 mg/m2 continuous dose vs 100 mg/m2 divided into three consecutive days in patients with head and neck squamous cell carcinoma , A Randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201220049776N1
Enrollment
60
Registered
2023-05-27
Start date
2019-12-11
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 Mali

Interventions

Intervention 1: Intervention group:In this group, they received cisplatin every 21 days at a dose of 100 mg per cubic meter divided into three consecutive days. Chemotherapy courses were between 2 an

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

Exclusion criteria: History of chemotherapy Kidney disease and Diabetes

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactArefeh Saeedian

Tehran University of Medical Sciences

a-saeedian@razi.tums.ac.ir+98 21 6119 2587

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026