Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

Study Overview
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Brief Summary
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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
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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: Patient receive at least 90% of radiation dose (18 of 20 fractions of 275cGy) Patients receive at least 3 of 4 weekly cycles of cisplatin (35mg/m2) Treatment length up to 35 days. Grade 4 toxicity lower than 25%

Official Title
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Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial

Conditions
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Radiotherapy; Complications

Intervention / Treatment
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* Radiation: Hypofractionated Radiotherapy
* Drug: Weekly cisplatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypofractionated chemoradiation<br>20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles | Radiation: Hypofractionated Radiotherapy<br>* 20 fractions of 275cGy 5 days/week<br>Drug: Weekly cisplatin<br>* Concomitant weekly cisplatin 35mg/m2 x 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | up to 5 years after patient accrual | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 18 months from treatment | 
| Response rate | as determined by investigators using RECIST v1.1 criteria | up to 4 months after patient accrual | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapy, complication