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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03194061
Other study ID # HIPO CP.
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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