Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region

Evaluation of clinical and dosimetric aspects, tolerance, and effectiveness of abdominal-pelvic region radiotherapy treatments in patients undergoing radiotherapy for primary or secondary neoplasms localized in the tabdominal-pelvic region.

Study Overview

• Status: Recruiting
• Conditions: Abdominal Cancer; Pelvic Cancer

Detailed Description

Approximately 60% of patients with neoplasms receive radiotherapy as part of their oncological treatment.

Various primary tumors as well as metastases of various origins can be localized in the abdominal-pelvic anatomical region.

Patients with such neoplastic localizations will therefore receive radiotherapy treatment possibly associated with other systemic or surgical treatments. Treatment choice is usually established following multidisciplinary discussions, based on disease characteristics and stage, concurrent pathologies and pharmacological treatments, patient preferences, and functional aspects.

Data collection related to radiotherapy plays a crucial role in understanding various clinical aspects of the treatment itself. The availability of data from an increasing number of patients will allow the identification of clinical situations or technical parameters of radiotherapy correlated with treatment tolerance and effectiveness, aiming to identify the best treatment for these oncological pathologies.

This project aims to collect data related to radiotherapy treatments for primary or secondary neoplasms of the abdominal-pelvic region for scientific dissemination with the goal of establishing the basis for evaluating achieved results over time, and deriving from these elements useful for guiding the most effective treatment strategies and appropriate operational protocols.

• Study Type: Observational
• Enrollment (Estimated): 7700

Contacts and Locations

• Study Contact: Name: Barbara Alicja Jereczek; Phone Number: +39 02 57489326; Email: barbara.jereczek@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Barbara Alicja Jereczek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated at European Institute of Oncology with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the abdominal-pelvic region

Description

Inclusion Criteria:

1. Patients treated with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the abdominal-pelvic region for:

   Primary tumors of the gastrointestinal tract, Primary tumors of the male and female reproductive systems, Primary tumors of the urinary system, Primary tumors of the cardio-circulatory system, Primary tumors of the lymphatic system, Primary tumors of the nervous system, Skin tumors, Secondary abdominal-pelvic localizations of various origins, Primary or secondary bone or soft tissue lesions of the lumbosacral spine and pelvis.

2. Signed informed consent

Exclusion Criteria:

1. Radiotherapy in districts other than the abdominal-pelvic region

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Radiotherapy to abdominal-pelvic region; Collection of data of patients receiving RT to abdominal-pelvic region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Number of patients death	5 years
Disease free survival	Number of oncological event (local recurrence, distant metastasis, other primary tumor)	5 years

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Barbara Alicja Jereczek, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 22, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): March 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pelvic Neoplasms
• Other Study ID Numbers: IEO 0729

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No