Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer

Radiotherapy; Complications Clinical Trial

— HIPOCP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03194061
• Other study ID #: HIPO CP.
• Status: Active, not recruiting
• Phase: N/A
• First received: April 24, 2017
• Last updated: January 17, 2018
• Start date: January 1, 2015
• Est. completion date: August 31, 2019

Study information

• Verified date: June 2017
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Radiotherapy; Complications

Intervention

Radiation:
• Hypofractionated Radiotherapy
20 fractions of 275cGy 5 days/week

Drug:
• Weekly cisplatin
Concomitant weekly cisplatin 35mg/m2 x 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Response rate	as determined by investigators using RECIST v1.1 criteria	up to 4 months after patient accrual