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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment | Active Comparator | patients in this group are treated with 3000 cGy in 10 daily fraction |
|
| short course treatment | Experimental | patients in this group are treated with 2000 cGy in 4 fractions administered twice a day (at least 6-8 hours interval) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard treatment | Radiation | 3000 cGy in 10 daily fractions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of palliation using the short course scheme compared with the standard scheme | reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| acute toxicity in the two treatment groups | incidence of treatment-related acute adverse events in the two arms of the study registered using Radiation Therapy Oncology Group (RTOG) Cooperative Group Common Toxicity Criteria | 3 months |
| late toxicity in the two treatment groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alessio G Morganti, MD | Contact | 0512143564 | +39 | alessio.morganti2@unibo.it |
| Name | Affiliation | Role |
|---|---|---|
| Alessio G Morganti, MD | Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine-DIMES, Unversity of Bologna, S. Orsola-Malpighi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology Center, Department of Experimental, Diagnostic and Speciality Medicine- DIMES, University of Bologna, S.Orsola-Malpighi Hospital | Recruiting | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| short course treatment |
| Radiation |
2000 cGy in 4 fractions administered twice a day |
|
incidence of treatment-related adverse events in the two arms of the study registered using RTOG/European Organisation for Research and Treatment of Cancer(EORTC) Late Radiation Morbility Scoring Schema |
| 12 months |
| Quality of Life (QoL) assessment in the two groups | changes in QoL after treatment assessed using a specific EORTC questionnaire developed to assess the quality of life of palliative cancer care patients (C15-PAL) | 12 months |
|