Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Unknown

Conditions: Radiotherapy; Head and Neck Cancer; Palliative Care

Treatments: Radiation: short course treatment; Radiation: standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03804073

RT 15-05 SHARON HEAD AND NECK

Details and patient eligibility

About

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic head and neck (H&N) malignant lesions

Full description

Standard treatment for H&N lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (2000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• symptomatic H&N malignant lesions (primary solid tumors or metastases from solid tumor)
• age>18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3
• no changes in supportive care in the week before radiotherapy

Exclusion criteria

• pregnancy
• previous irradiation of the same region

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

standard treatment

Active Comparator group

Description:

patients in this group are treated with 3000 cGy in 10 daily fraction

Treatment:

Radiation: standard treatment

short course treatment

Experimental group

Description:

patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

Treatment:

Radiation: short course treatment