Neoplasms

All Conditions

Head and Neck Neoplasms

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

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

standard treatment

2000 cGy in 4 fractions administered twice a day

short course treatment

Alessio G Morganti, MD

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

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

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Head and Neck Cancer: an Interventional, Randomized, Multicentric Study

reduction of initial symptoms (pain, bleeding, dysphagia, hoarseness, stridor, dehydration, malnutrition) after radiotherapy, evaluated as none-mild-moderate-severe before and after treatment

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

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

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)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Professor

Symptoms and General Pathology

Nervous System Diseases

Neoplasm Metastasis

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

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

patients in this group are treated with 1800 cGy in 4 fractions administered twice a day (at least 6-8 hours interval)

1800 cGy in 4 fractions administered twice a day

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors

Standard treatment for brain metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Short Course Radiation Therapy in Palliative Treatment of Brain Metastases

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Brain Metastases: an Interventional, Randomised, Multicentric Study

Reduction of initial symptoms after radiotherapy, assessed with Likert scale (weakness, motor disorders, cognitive impairment, personality changes, loss of balance, seizures, changes in speech, vision, hearing, memory problems, nausea or vomiting are evaluated as none-mild-moderate-severe)

Incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria

Incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema

Changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients)

Digestive System Diseases

Rare Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic esophageal malignant lesions

Standard treatment for esophageal 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

Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Esophageal Cancer: an Interventional, Randomized, Multicentric Study

reduction of initial symptoms after radiotherapy, assessed with Likert scale (dysphagia, odynophagia, regurgitation, chest-back pain are evaluated as none-mild-moderate-severe)

incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria

incidence of treatment-related adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbility Scoring Schema

changes in QoL after the treatment assessed using European Organization for Research and Treatment of Cancer (EORTC) questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the quality of life of palliative cancer care patients)

Thoracic Neoplasms

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic thoracic malignant lesions

Standard treatment for thoracic 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

Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Thoracic Cancer: an Interventional, Randomized, Multicentric Study

reduction of initial symptoms after radiotherapy, assessed with Likert scale (pain, bleeding, coughing, dysphagia, dyspnea, brachial plexopathy, lymphedema)

incidence of treatment-related acute adverse events in the two arms of the study registered using Cooperative Group Common Toxicity Criteria (RTOG)

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

changes in QoL after the treatment assessed using EORTC questionnaire C15-PAL (a specific questionnaire from EORTC developed to assess the QoL of palliative cancer care patients)

Abdominal Neoplasms

Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic abdominal malignant lesions

Standard treatment for abdomen lesions (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (1800 cGy in 4 fractions of 450 cGy twice a day) to demonstrate non-inferiority of this scheme

Short Course Radiation Therapy in Palliative Treatment of Abdominal Cancer

SHort Course Accelerated RadiatiON Therapy (SHARON) in Palliative Treatment of Abdominal Cancer: an Interventional, Randomized, Multicentric Study

Reduction of initial symptoms after radiotherapy, assessed with Likert scale (bleeding, nausea or vomiting, diarrhea, malnutrition, jaundice, weight loss, bowel obstruction are evaluated as none-mild-moderate-severe)

Musculoskeletal Diseases

Blood and Lymph Conditions

Bone Neoplasms

Bone Marrow Diseases

Bone Diseases

Hematologic Diseases

Patients in this group are treated with 3000 cGy in 10 daily fractions

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

Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.

Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

SHort Course Accelerated RadiatiON Therapy (SHARON) in Complicated Bone Metastases Palliation: an Interventional, Randomised, Multicentric Study

Reduction of pain after radiotherapy, assessed with VAS (visual analogue scale)

incidence of treatment-related late adverse events in the two arms of the study registered using RTOG/EORTC Late Radiation Morbidity Scoring Schema

Changes in QoL after the treatment assessed using EORTC questionnaires (QLQ-BM22 and C15-PAL)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Short Course Radiation Therapy in Palliative Treatment of Head and Neck Cancer	NCT03804073	Head and Neck C... Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Short Course Radiation Therapy in Palliative Treatment of Brain Metastases	NCT03525301	Brain Metastase... Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer	NCT03804203	Esophageal Canc... Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Short Course Radiation Therapy in Palliative Treatment of Thoracic Cancer	NCT03804307	Thoracic Cancer Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Short Course Radiation Therapy in Palliative Treatment of Esophageal Cancer	NCT03804203	Esophageal Canc... Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Short Course Radiation Therapy in Palliative Treatment of Abdominal Cancer	NCT03775005	Abdomen Tumors Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna
Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases	NCT03503682	Bone Metastases Radiotherapy Palliative Care	standard treatm... short course tr...	18 Years -	IRCCS Azienda Ospedaliero-Universitaria di Bologna

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