Evaluation of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Uterine Neoplasms

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

The single-center observational study aims to collect data related to the radiation treatment of uterine neoplasms. The purpose of the study is to systematically gather data on radiation treatment in uterine neoplasms in order to evaluate tumor response and potential toxicity in relation to dosages, fractionation, and techniques used, as well as the combination with other therapies and the characteristics of the disease.

Additionally, collecting data on both the characteristics of the disease and patients' comorbidities in a large sample may allow for the evaluation of any possible correlation with radiation-induced toxicities, with the aim of being able to predict and prevent them in a personalized manner in the future.

Therefore, the study's goal is to evaluate tumor response and any potential toxicity after radiotherapy treatment in relation to treatment settings, dosages, and techniques used, both for new diagnoses and for cases already diagnosed and treated from 01/01/2000 onwards at the Radiotherapy Unit of Sant'Orsola-Malpighi Polyclinic.

The structured collection of data necessary for the evaluation of the objectives will cover the observation period from 01/01/2000 to 15/12/2030, for a total of approximately 5000 patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm, starting from 01/01/2000, treated at the Radiotherapy Unit of the Sant'Orsola Polyclinic

Obtaining informed consent

Disqualifiers

Patients with a new or previous diagnosis of malignant uterine neoplasm who choose not to undergo radiation treatment at the Radiotherapy Unit of the Sant'Orsola Polyclinic

Trial population

Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Local disease recurrence

To evaluate the outcome, particularly in terms of local disease recurrence, after radiation treatment of uterine neoplasms, in relation to the treatment setting, dosages, and techniques used, both for newly diagnosed neoplasms and for cases already diagnosed and treated since 01/01/2000 at the Sant'Orsola Polyclinic, Bologna University Hospital.

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

Secondary outcomes

1

Acute toxicity

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

Time frame
immediate to 6 months after radiotherapy
2

Late toxicity

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

Time frame
from 6 months after radiotherapy, through study completion, an average of 1 year
3

Incidence of retreatments and their characteristics

Time frame
During follow ups through study completion, an average of 1 year
4

Disease-free survival of the patients

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

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

Other outcomes

Sponsors and contacts

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