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

NCT06774482RecruitingOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

3000

Start Date

2021-05-19

Completion Date

2030-12-31

Study Type

OBSERVATIONAL

Official Title

Evaluation of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Uterine Neoplasms Treated With Radiotherapy at the Sant'Orsola Polyclinic in Bologna.

Conditions

Uterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Outcome Measures

Primary Outcomes

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

Acute toxicity

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

Time frame: immediate to 6 months after radiotherapy

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

Incidence of retreatments and their characteristics

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

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

Overall survival

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

Locations

IRCCS Azienda Ospedaliero - Universitaria di Bologna, Bologna, Italy

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.

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