Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study wants to define the maximum tolerated dose (MTD), safety and efficacy of a short course radiation treatment in patients with symptomatic advanced head and neck cancer.
The study wants to define the maximum tolerated dose (MTD) of a conformal short course accelerated radiation therapy delivered in twice daily fractions and 2 consecutive days, and the feasibility of this fractionation in term of safety and efficacy for symptomatic palliation of metastatic or locally advanced head and neck cancer.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short course radiotherapy | Experimental | The radiotherapy is delivered over two days with accelerated hypo-fractionation was delivered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short course radiotherapy | Radiation | An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | The maximum tolerated dose is defined as the dose level below the highest administered dose associated with dose limiting toxicity (DLT) in at least one third of patients | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Acute toxicity after treatment is evaluated with CTCAE scale | 1 year |
| Quality of life | Quality of life after the treatment is evaluated according to CLAS scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alessio G. Morganti, MD | Radiation Oncology Center, Department of Experimental, Diagnostic and Specialty Medicine - DIMES, University of Bologna, S. Orsola-Malpighi Hospital, Bologna, Italy | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Pain relief | Pain after the therapy is evaluated with the visual analogic scale | 1 year |
| Late toxicity | Late toxicity after the treatment is evaluated with EORTC-RTOG scale | 1 year |
| D013568 |
| Pathological Conditions, Signs and Symptoms |