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NCT Number: NCT06760806

Evaluation of Toxicities in Patients Treated With Palliative Radiotherapy at Policlinico Sant Orsola of Bologna.

The aim of the study is to assess the outcome in palliative patients, particularly in terms of symptom resolution or alleviation, after radiation treatment of the various tumours analysed, in relation to the treatment setting, dosages and techniques used both for newly diagnosed tumours and for cases already diagnosed and treated at the Radiotherapy Unit of the Sant Orsola Hospital.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Alessio Giuseppe Morganti, MD

CONTACT

[email protected]

+39 0516363136

About this study

Malignant neoplasms are frequent in the general population, particularly in countries with a high development index. In Europe, the incidence of malignant tumours in 2018 was almost 570 cases/100,000 inhabitants, while mortality in the same year was over 260 cases/100,000 inhabitants. In Italy, more than 175,000 new cancers were diagnosed in 2018, while the prevalence of malignant neoplasms in our country is 1990 cases/100,000 inhabitants. The therapy of neoplastic pathology is in most cases multimodal, and the various treatments can be adjuvant or neoadjuvant depending on the neoplasm treated and the strategy adopted from time to time. In addition, radiotherapy can play a key role in advanced disease, either with curative intent or with palliative intent on symptoms. Radiotherapy is one of the most effective means of providing palliation of cancer symptoms. The location of the symptom is essential to define a correct treatment plan, as the therapeutic approach will be different if the symptom is caused by the locally advanced primary tumour or by metastases. The symptoms most commonly relieved with palliative radiotherapy are pain, bleeding and obstruction.

Bone metastases are the most frequent cause of cancer-related pain and over 70% of patients with bone metastases are symptomatic. One of the most important goals in the treatment of bone metastases is to alleviate suffering and maintain an ability to manage daily activities. Radiotherapy plays a key role in improving the quality of life of these patients. Dosages, fractionations and techniques vary depending on the type of neoplasm treated, fractionations and techniques vary depending on the type of neoplasm treated, its location and the type of symptom to be palliated, as do the possible acute and late toxicities in relation to the characteristics of the treatment and, of course, the anatomical region irradiated. Systematic collection of data on palliative radiation treatment in different malignancies may make it possible to assess outcomes in relation to dosages, fractionation and techniques adopted in combination with other therapies, with the characteristics of the disease (bioprofile, histotype, stage, etc.) and of the patient (age, gender, comorbidities, etc...) The aim of the study is to evaluate the outcome in palliative patients, particularly in terms of symptom resolution or alleviation, after radiation treatment of the different tumours analysed, in relation to treatment setting, dosages and techniques used both for new neoplasm diagnoses and for cases already diagnosed and treated at the Radiatherapy Department of Sant Orsola Hospital.

The study is observational, retrospective and prospective, single-centre, spontaneous.

The structured collection of data necessary for the evaluation of the objectives will cover the period of observation period from 01/01/2000 to 31/12/2027.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients of either sex with a new or previous diagnosis of malignant neoplasm since 1st January 2000
  • patients treated with paliative radiotherapy
  • obtaining of informed consent

Exclusion criteria

  • adult patients of either sex with a new or previous diagnosis of malignant neoplasm who choose not to undergo radiotherapy treatment
  • patients enrolled in other studies
  • pregnant or breastfeeding women

Treatment and study plan

Primary outcomes

  1. Symptom resolution or attenuation

    Time frame: From the start of therapy to the last follow-up at 12 months

    Evaluate the outcome in palliative patients, particularly in terms of symptom resolution or alleviation, after radiation treatment of the different tumours analysed, in relation to the treatment setting, dosages and techniques used

Secondary outcomes

  1. Acute toxicity in relation to different radiotherapy disages and techniques and patient characteristics

    Time frame: immediate to 6 months after radiotherapy

    acute toxicity after radiotherapy, evaluated according to CTCAE v.5

  2. Late toxicity in relation to different radiotherapy disages and techniques and patient characteristics

    Time frame: from 6 months after radiotherapy, through study completion, an average of 1 year

    late toxicity after completion of treatments, evaluated according to CTCAE v.5

  3. Incidence of reprocessing and its characteristics

    Time frame: During follow ups through study completion, an average of 1 year

  4. Symptom-free survival

    Time frame: During the follow-ups, up to the last one at 12 months

    Disease-free survival assessed based on the presence or absence of local, nodal, or metastatic recurrences

  5. Overall survival

    Time frame: From enrollment to the last follow-up at 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alessio Giuseppe Morganti, MD

CONTACT

[email protected]

0512143564

Costanza Maria Donati, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Evaluation of Toxicities in Patients Treated With Palliative Radiotherapy at Policlinico Sant Orsola of Bologna - patieNts treAted wIth palliatiVe radiothErapy - NAIVE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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