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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated chemoradiation | Experimental | 20 fractions of 275cGy and concomitant weekly cisplatin 35mg/m2 x 4 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated Radiotherapy | Radiation | 20 fractions of 275cGy 5 days/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre A Jacinto, MD | Barretos Cancer Hospital | Principal Investigator |
| Andre Lopes Carvalho, Phd | Barretos Cancer Hospital | Study Director |
| Luciano Souza Viana, Phd | Barretos Cancer Hospital | Study Chair |
| Pedro de Marchi | Barretos Cancer Hospital | Study Chair |
| Eronides Salustiano Batalha | Barretos Cancer Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30352576 | Derived | Jacinto AA, Batalha Filho ES, Viana LS, De Marchi P, Capuzzo RC, Gama RR, Boldrini Junior D, Santos CR, Pinto GDJ, Dias JM, Canton HP, Carvalho R, Radicchi LA, Bentzen S, Zubizarreta E, Carvalho AL. Feasibility of concomitant cisplatin with hypofractionated radiotherapy for locally advanced head and neck squamous cell carcinoma. BMC Cancer. 2018 Oct 23;18(1):1026. doi: 10.1186/s12885-018-4893-5. |
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| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Weekly cisplatin | Drug | Concomitant weekly cisplatin 35mg/m2 x 4 weeks |
|
as determined by investigators using RECIST v1.1 criteria |
| up to 4 months after patient accrual |