FindTrial
Sign In

Complication assessment of chemotherapy with radiotherapy in head and neck tumors

The comparison of acute toxicities and loading dose of drug in weekly and three - weekly Cisplatin delivered concomitant with radiotherapy in Squamous cell carcinoma of head and neck.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015112225185N1
Enrollment
90
Registered
2015-12-05
Start date
2015-02-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Condition 1: Head and neck tumor. Condition 2: Head and neck tumor. Condition 3: Head and neck tumor. Condition 4: Head and neck tumor. Condition 5: Head and neck tumor. Condition 6: Head and neck tumor. Condition 7: Head and neck tumor. Condition 8: Head and neck tumor. Condition 9: Head and neck tumor. Condition 10: Head and neck tumor. Condition 11: Head and neck tumor. Condition 12: Head and neck tumor. Malignant neoplasm of lip Malignant neoplasm of base of tongue Malignant neoplasm of g

Interventions

Intervention 1: In the first group IV Cisplatin will be administered with the dose of 40 mg/ m2 once weekly concurrently with radiotherapy. Intervention 2: In the second group IV Cisplatin will be a
Treatment - Drugs
In the first group IV Cisplatin will be administered with the dose of 40 mg/ m2 once weekly concurrently with radiotherapy
In the second group IV Cisplatin will be administered three- weekly with the dose of 100 mg/m2 concurrently with radiotherapy

Sponsors

Ahvaz University Of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
75 Years to 23 Years

Inclusion criteria

Inclusion criteria: (Inclusion criteria: Pathologic report of Squamous.cell.carcinoma ; Age 18- 70 years ; ECOG performance status of 0-1; No distant metastasis; WBC equal to more than 4000; PLT equal to more than 100000; Hb equal to more than 10; Serum Cr less than 1.5 ; Serum aminotransferase less than twice of normal range.) (Exclusion criteria: Sever medical or psychiatric disorder; Patient who dose not have a good fallow up.)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Hematologic disorders. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: CBC markers.;Neutropenic fever. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: CBC markers and oral temperature.;Renal disorders. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Serum Cr.;GI disorders. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Clinical presentation of acute and chronic nausea and vomiting /oral mucositis/more than twice of normal range of liver enzymes.;Stopping the treatment. Timepoint: During treatment time. Method of measurement: With each complications.;Hypersensitivity reaction. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Clinical presentation.;Sensory neuropathy. Timepoint: Befor start of treatment then weekly in first group and three weekly in second group. Method of measurement: Clinical presentation of paresthesia in hands and feet.;Accumulative dose. Timepoint: End of treatment. Method of measurement: Accumulation of all drug doses during treatment.—

Secondary

MeasureTime frame
Stage of disease. Timepoint: Start of treatment. Method of measurement: TNM system.—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Hojatolah Shahbazian

Ahvaz, Golestan Hospital,Radiotherapy Ward

hjshahbazian@yahoo.com somaye.barihi@gmail.com+98 61 3374 3057

Outcome results

None listed

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