The aim of this study is to evaluate the feasibility of hypofractionated radiation therapy and concomitant chemotherapy with cisplatin for locally advanced head and neck cancer in a high volume brazilian center.
To evaluate if concomitant cisplatin and hypofractionated radiation therapy wold be feasible in a brazilian population. Patients eligibility criteria: older than 18 years old Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx. Stage III an IV, with no distant metastasis. ECOG performance status 0-2. Adequate renal and liver function. Good status for radical treatment Treatment considered feasible if: 1. Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy) 2. Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2) 3. Treatment length up to 35 days. 4. Grade 4 toxicity lower than 25%
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
20 fractions of 275cGy 5 days/week
Concomitant weekly cisplatin 35mg/m2 x 4 weeks
To evaluate the rate of patient who could complete the treatment.
The treatment is considered completed when patients receive at least 90% of radiation dose (49,5Gy) with a cumulative cisplatin dose of 105mg/m2 or more (3 of 4 cycles) and the treatment duration is inferior to 35 consecutive days.
Time frame: up to 5 years after patient accrual
To evaluate the rate of participants with treatment-related adverse events
as assessed by investigators using the CTCAE v4.0 criteria
Time frame: up to 5 years after patient accrual
Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)
Frequency and intensity of symptoms as described by patients before treatment (baseline), at the end of treatment, 1 month, 7 months and after 1 year following the treatment.
Time frame: up to 18 months from treatment
Response rate
as determined by investigators using RECIST v1.1 criteria
Time frame: up to 4 months after patient accrual
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