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Palliative CareNCT06760806

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

An observational study of Palliative Care, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Palliative Care
How many people
7,000 participants
Where
1 siteItaly
Study dates
21 Jan 2021to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Every patient with a neoplastic disease admitted to the radiotherapy department for palliative or follow-up radiation treatment.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alessio Giuseppe Morganti, MD contact

0512143564

alessio.morganti2@unibo.it

Costanza Maria Donati, MD contact

costanzamaria.donati@unibo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero - Universitaria di Bologna

    Bologna, 40138

    Alessio Giuseppe Morganti, MD, +39 0516363136, alessio.morganti2@unibo.it

    Recruiting

Other trials in Italy

About this study

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

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.

Read the detailed description

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.

Conditions
Palliative Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom resolution or attenuation

    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

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

Secondary outcomes (5)
  1. Acute toxicity in relation to different radiotherapy disages and techniques and patient characteristics

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

    Measured: immediate to 6 months after radiotherapy

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

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

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

  3. Incidence of reprocessing and its characteristics

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

  4. Symptom-free survival

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

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

  5. Overall survival

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start21 Jan 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760806
Sponsor's protocol ID
NAIVE
Status last verified
Sep 2024
First submitted
1 Dec 2024
Last updated
7 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Palliative Care, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alessio Giuseppe Morganti, MD (0512143564, alessio.morganti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom resolution or attenuation (time frame: From the start of therapy to the last follow-up at 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.

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