Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

Not Applicable

• Conditions: Radiotherapy; Complications
• Interventions: Radiation: Hypofractionated Radiotherapy; Drug: Weekly cisplatin

• Registration Number: NCT03194061
• Lead Sponsor: Barretos Cancer Hospital

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%

Study Timeline

• Study Start: 2015-01-01
• Study First Submitted: 2017-04-24
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-21
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-19
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hypofractionated chemoradiation	Weekly cisplatin	20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
Hypofractionated chemoradiation	Hypofractionated Radiotherapy	20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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