Clinical trial NCT03194061: Hypofractionated Radiotherapy and Concurrent Cisplatin for Head and Neck Cancer
Official title: Hypofractionated Radiotherapy and Concurrent Cisplatin for Locally Advanced Head and Neck Cancer: A Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy; Complications
Keywords: chemotherapy
complication
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the rate of patient who could complete the treatment.
timeFrame: up to 5 years after patient accrual
measure: To evaluate the rate of participants with treatment-related adverse events
timeFrame: up to 5 years after patient accrual
Secondary outcomes:
measure: Quality of life according to the EORTC C30 questionaire and EORTC H&N 35 (evaluated together)
timeFrame: up to 18 months from treatment
measure: Response rate
timeFrame: up to 4 months after patient accrual
Other outcomes:
Locations:
Study officials:
affiliation: Barretos Cancer Hospital
name: Alexandre A Jacinto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos Cancer Hospital
name: Andre Lopes Carvalho, Phd
role: STUDY_DIRECTOR
affiliation: Barretos Cancer Hospital
name: Luciano Souza Viana, Phd
role: STUDY_CHAIR
affiliation: Barretos Cancer Hospital
name: Pedro de Marchi
role: STUDY_CHAIR
affiliation: Barretos Cancer Hospital
name: Eronides Salustiano Batalha
role: STUDY_CHAIR
References:
citation: 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.