Radiotherapy; Complications
Conditions
Keywords
chemotherapy, complication
Brief summary
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.
Detailed description
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%
Interventions
RADIATIONHypofractionated Radiotherapy
20 fractions of 275cGy 5 days/week
DRUGWeekly cisplatin
Concomitant weekly cisplatin 35mg/m2 x 4 weeks
Sponsors
Barretos Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Other oncologic treatment before * Distant metastasis * History of previous malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the rate of patient who could complete the treatment. | up to 5 years after patient accrual | 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. |
| To evaluate the rate of participants with treatment-related adverse events | up to 5 years after patient accrual | as assessed by investigators using the CTCAE v4.0 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together) | up to 18 months from treatment | 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. |
| Response rate | up to 4 months after patient accrual | as determined by investigators using RECIST v1.1 criteria |
Outcome results
None listed