Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer (HIPOCP)
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|ClinicalTrials.gov Identifier: NCT03194061|
Recruitment Status : Unknown
Verified June 2017 by Barretos Cancer Hospital.
Recruitment status was: Active, not recruiting
First Posted : June 21, 2017
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Radiotherapy; Complications||Radiation: Hypofractionated Radiotherapy Drug: Weekly cisplatin||Not Applicable|
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%
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial|
|Actual Study Start Date :||January 1, 2015|
|Estimated Primary Completion Date :||August 31, 2019|
|Estimated Study Completion Date :||August 31, 2019|
Experimental: Hypofractionated chemoradiation
20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles
Radiation: Hypofractionated Radiotherapy
20 fractions of 275cGy 5 days/week
Drug: Weekly cisplatin
Concomitant weekly cisplatin 35mg/m2 x 4 weeks
- 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
- Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together) [ Time Frame: 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 [ Time Frame: up to 4 months after patient accrual ]as determined by investigators using RECIST v1.1 criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03194061
|Principal Investigator:||Alexandre A Jacinto, MD||Barretos Cancer Hospital|
|Study Director:||Andre Lopes Carvalho, Phd||Barretos Cancer Hospital|
|Study Chair:||Luciano Souza Viana, Phd||Barretos Cancer Hospital|
|Study Chair:||Pedro de Marchi||Barretos Cancer Hospital|
|Study Chair:||Eronides Salustiano Batalha||Barretos Cancer Hospital|