Abdominal CancerNCT06335238
Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region
An observational study of Abdominal Cancer and Pelvic Cancer, run by European Institute of Oncology at 1 site in Italy.
Trial summary
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 abdominal-pelvic region. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer, Pelvic Cancer
- How many people
- 7,700 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated at European Institute of Oncology with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the abdominal-pelvic region
Who may be able to join
- 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.
- Signed informed consent
Who cannot join
- 1. Radiotherapy in districts other than the abdominal-pelvic region
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Barbara Alicja Jereczek
About this study
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 abdominal-pelvic region.
Read the 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.
- Conditions
- Abdominal Cancer, Pelvic Cancer
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy to abdominal-pelvic region | Collection of data of patients receiving RadioTherapy (RT) to abdominal-pelvic region |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Number of patients death
Measured: 5 years
Disease free survival
Number of oncological event (local recurrence, distant metastasis, other primary tumor)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start22 Feb 2018
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Alicja Jereczek, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335238
- Sponsor's protocol ID
- IEO 0729
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy Treatments for Neoplasms in the Abdominal-pelvic Region
- ClinicalTrials.gov ID
- NCT06335238
- Acronym / sponsor ID
- IEO 0729
- Conditions
- Abdominal Cancer, Pelvic Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,700 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 abdominal-pelvic region.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy to abdominal-pelvic region | – | –Collection of data of patients receiving RadioTherapy (RT) to abdominal-pelvic region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated at European Institute of Oncology with radiotherapy for curative, palliative, neo-adjuvant, and adjuvant purposes in the abdominal-pelvic region
Key inclusion criteria (3 listed)
- 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.
- Signed informed consent
Key exclusion criteria (1 listed)
- 1. Radiotherapy in districts other than the abdominal-pelvic region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 years
Number of patients death
Disease free survival
Time frame: 5 years
Number of oncological event (local recurrence, distant metastasis, other primary tumor)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Alicja Jereczek principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Cancer and Pelvic Cancer, run by European Institute of Oncology 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 1 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Alicja Jereczek (+39 02 57489326, barbara.jereczek@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). The study lists 2 primary outcomes in all. 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 5 Aug 2024.