Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
Overview
- Phase
- N/A
- Intervention
- Hypofractionated Radiotherapy
- Conditions
- Radiotherapy; Complications
- Sponsor
- Barretos Cancer Hospital
- Enrollment
- 20
- Primary Endpoint
- To evaluate the rate of patient who could complete the treatment.
- Last Updated
- 8 years ago
Overview
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%
Investigators
Eligibility Criteria
Inclusion Criteria
- •Biopsy proven squamous cell carcinoma of oropharynx, larynx and hypopharynx.
- •Stage III an IV, with no distant metastasis.
- •ECOG performance status 0-
- •Adequate renal and liver function.
- •Good status for radical treatment
Exclusion Criteria
- •Other oncologic treatment before
- •Distant metastasis
- •History of previous malignancy
Arms & Interventions
Hypofractionated chemoradiation
20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
Intervention: Hypofractionated Radiotherapy
Hypofractionated chemoradiation
20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
Intervention: Weekly cisplatin
Outcomes
Primary Outcomes
To evaluate the rate of patient who could complete the treatment.
Time Frame: 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
Time Frame: up to 5 years after patient accrual
as assessed by investigators using the CTCAE v4.0 criteria
Secondary Outcomes
- Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)(up to 18 months from treatment)
- Response rate(up to 4 months after patient accrual)