Squamous cell carcinoma of head and neck
Conditions
Interventions
Consenting patients meeting inclusion/exclusion criteria will be randomized into two arms.
Participants in the low-dose Cisplatin arm (arm 1) will receive Cisplatin at 40 mg/m2 once per week for 6 c
Sponsors
National Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients between 18-70 years of age 2. Histologically confirmed squamous cell carcinoma of head and neck who need chemoradiation 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 4. Fitness for chemoradiotherapy as determined by detailed history, a clinical examination and following investigations ie: (i). Full Blood Count (ii) Serum creatinine (iii) 24 hour creatinine clearance test (iv) Urine full report (v) Ultrasound assessment of kidneys, bladder, ureter and liver (vi) Echo cardiogram (vii) Serum Magnesium (viii) Chest X ray
Exclusion criteria
Exclusion criteria: 1. Patients above 70 years and below 18 years of age 2. Bone erosion or distantmetastasis 3. Pregnancy and lactation 4. Past history of any malignancy or treatment with cytotoxic drugs 5. Eastern Cooperative Oncology Group (ECOG) performance status > =3 6. Patients who are not fit for chemotherapy with Cisplatin 7. Initial FBC below normal range (WBC <4000, absolute neutrophil count <1500, platelet count of <1 00 000/mm3) 8. Initial 24 hour creatinine clearance below 60mmol/hr/1.72m2 9. Patients having abnormalities of urinary system on ultra sound scan other than simple cyst 10. Low Cardiac function (Left ventricular ejection fraction below 55%) 11. Existing comorbidity in which hyper hydration is not indicated 12. Patients with any other systemic disease which render high risk for side effects chemotherapy or radiotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity of the therapy (according to the WHO Grading System in “Toxicity Criteria”. Myelosupression, mucositis, renal toxicity, skin reactions and hearing defect, peripheral sensory loss will be assessed as the indicators of toxicity). [Weekly in all arms, until the treatment is complete.] | — |
Secondary
| Measure | Time frame |
|---|---|
| Body weight [Weekly in all arms, until the treatment is complete.] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. S. P. Weerasinghe
Consultant Clinical Oncologist
Outcome results
None listed