Head and Neck CancerNCT06773039
Assessment of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy
An observational study of Head and Neck Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
This is a monocentric observational study aimed at collecting data related to the radiotherapy treatment of head and neck neoplasms. The purpose of the study is to systematically gather data on radiotherapy for head and neck neoplasms to evaluate tumor response and potential toxicity in relation to dosages and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2021to 15 Dec 2030
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with new or previous diagnosis of malignant neoplasm of the head and neck
Who may be able to join
- Patients of both sexes, aged ≥ 18 years, with new or previous diagnosis of malignant neoplasm of the head and neck, from January 1, 2000, treated at the Radiotherapy Unit of the S. Orsola Polyclinic
- Obtaining informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, 40138
Alessio Giuseppe Morganti, MD, +39 0516363136, alessio.morganti2@unibo.it
Alessio Giuseppe Morganti, MD
About this study
Official title: Assessment of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna
This is a monocentric observational study aimed at collecting data related to the radiotherapy treatment of head and neck neoplasms. The purpose of the study is to systematically gather data on radiotherapy for head and neck neoplasms to evaluate tumor response and potential toxicity in relation to dosages and techniques used, the combination with other therapies, disease characteristics, and the psychological impact of the proposed treatments.
Additionally, collecting data on both disease characteristics and pre-existing conditions in a large sample may allow for the assessment of any correlation with radiation-induced toxicities, with the goal of predicting and preventing them in a personalized manner in the future.
The study's aim is thus to evaluate tumor response and any potential toxicity following radiotherapy treatment concerning treatment modalities, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola-Malpighi Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients. Participation in the study solely involves the structured collection of certain information already present in your medical records, as well as data related to clinical exams, radiological imaging, and therapies, without any modifications to standard clinical practice. Participation in the study incurs no costs and will not be compensated in any way. There are no risks or inconveniences associated with participating in this study. Enrolled patients will not receive any direct benefit from this study, as it is purely a data collection effort. The collected data will enhance understanding of the factors associated with treatment outcomes, ultimately leading to improved management of each individual patient.
Read the detailed description
Head and neck tumors refer to neoplasms that originate in the nasal cavities and paranasal sinuses, rhinopharynx/oropharynx/hypopharynx, salivary glands, oral cavity, and larynx, mostly represented by squamous cell carcinomas. Head and neck tumors account for 4.9% of all malignant tumors worldwide.
Treatment is mostly multimodal; the main therapeutic options include surgery, systemic therapy, and radiotherapy. Various treatments may serve as primary or adjuvant therapy depending on the specific neoplasm and the strategy adopted.
Regarding radiotherapy, it is often used in combination with other treatments depending on the stage, location of the disease, risk factors, or in a palliative setting. Dosages, fractionation, and techniques vary based on the type of neoplasm being treated and the purpose of the therapy (adjuvant, radical, palliative), as do the possible acute and late toxicities related to the treatment characteristics.
The purpose of the study is to systematically collect data related to radiotherapy treatment in head and neck neoplasms in order to evaluate outcomes in relation to dosages, fractionation, and techniques used, as well as combinations with other therapies and disease characteristics. Additionally, collecting data on both disease characteristics and treatments in a large sample may enable the assessment of any potential correlation with radiation-induced toxicities, allowing for future prediction and personalized prevention.
Enrolled patients will not have any direct benefit or harm from their participation in the study, as it is solely a data collection effort. Conversely, these data may lead to new insights that improve the management of the analyzed neoplastic diseases in the future.
The study thus aims to evaluate outcomes, toxicity, and the psychological impact on patients related to radiotherapy treatment concerning treatment settings, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients (2,000 for the retrospective phase and 1,000 for the prospective phase).
- Conditions
- Head and Neck Cancer
- Medical subject headings
- Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation of therapy response
Evaluate the correlation of therapy response with other parameters in the radiotherapy treatment of head and neck neoplasms, considering the treatment setting, dosages, and techniques used
Measured: From enrollment to the last follow-up at 12 months
Secondary outcomes (6)
Acute toxicity
acute toxicity after radiotherapy, evaluated according to CTCAE v.5
Measured: immediate to 6 months after radiotherapy
Late toxicity
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
Impact on the patient's quality of life
The impact on patients' quality of life will be assessed through the submission of questionnaires (FACT H\&N)
Measured: From enrollment to the last follow-up at 12 months
Retreatments
Retreatments yes or not
Measured: During the follow-ups, up to the last one at 12 months
Disease-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
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.
- First posted14 Jan 2025
- Study start28 Oct 2021
- Primary completion15 Nov 2030 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessio Giuseppe Morganti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773039
- Sponsor's protocol ID
- PORTO
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2024
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna
- ClinicalTrials.gov ID
- NCT06773039
- Acronym / sponsor ID
- PORTO
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 28 Oct 2021 (actual)
- Primary completion
- 15 Nov 2030 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 14 Jan 2025 (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.
This is a monocentric observational study aimed at collecting data related to the radiotherapy treatment of head and neck neoplasms. The purpose of the study is to systematically gather data on radiotherapy for head and neck neoplasms to evaluate tumor response and potential toxicity in relation to dosages and techniques used, the combination with other therapies, disease characteristics, and the psychological impact of the proposed treatments.
Additionally, collecting data on both disease characteristics and pre-existing conditions in a large sample may allow for the assessment of any correlation with radiation-induced toxicities, with the goal of predicting and preventing them in a personalized manner in the future.
The study's aim is thus to evaluate tumor response and any potential toxicity following radiotherapy treatment concerning treatment modalities, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola-Malpighi Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients. Participation in the study solely involves the structured collection of certain information already present in your medical records, as well as data related to clinical exams, radiological imaging, and therapies, without any modifications to standard clinical practice. Participation in the study incurs no costs and will not be compensated in any way. There are no risks or inconveniences associated with participating in this study. Enrolled patients will not receive any direct benefit from this study, as it is purely a data collection effort. The collected data will enhance understanding of the factors associated with treatment outcomes, ultimately leading to improved management of each individual patient.
Detailed description
Head and neck tumors refer to neoplasms that originate in the nasal cavities and paranasal sinuses, rhinopharynx/oropharynx/hypopharynx, salivary glands, oral cavity, and larynx, mostly represented by squamous cell carcinomas. Head and neck tumors account for 4.9% of all malignant tumors worldwide.
Treatment is mostly multimodal; the main therapeutic options include surgery, systemic therapy, and radiotherapy. Various treatments may serve as primary or adjuvant therapy depending on the specific neoplasm and the strategy adopted.
Regarding radiotherapy, it is often used in combination with other treatments depending on the stage, location of the disease, risk factors, or in a palliative setting. Dosages, fractionation, and techniques vary based on the type of neoplasm being treated and the purpose of the therapy (adjuvant, radical, palliative), as do the possible acute and late toxicities related to the treatment characteristics.
The purpose of the study is to systematically collect data related to radiotherapy treatment in head and neck neoplasms in order to evaluate outcomes in relation to dosages, fractionation, and techniques used, as well as combinations with other therapies and disease characteristics. Additionally, collecting data on both disease characteristics and treatments in a large sample may enable the assessment of any potential correlation with radiation-induced toxicities, allowing for future prediction and personalized prevention.
Enrolled patients will not have any direct benefit or harm from their participation in the study, as it is solely a data collection effort. Conversely, these data may lead to new insights that improve the management of the analyzed neoplastic diseases in the future.
The study thus aims to evaluate outcomes, toxicity, and the psychological impact on patients related to radiotherapy treatment concerning treatment settings, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients (2,000 for the retrospective phase and 1,000 for the prospective phase).
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with new or previous diagnosis of malignant neoplasm of the head and neck
Key inclusion criteria (2 listed)
- Patients of both sexes, aged ≥ 18 years, with new or previous diagnosis of malignant neoplasm of the head and neck, from January 1, 2000, treated at the Radiotherapy Unit of the S. Orsola Polyclinic
- Obtaining informed consent
Key exclusion criteria (1 listed)
- None
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
Evaluate the correlation of therapy response
Time frame: From enrollment to the last follow-up at 12 months
Evaluate the correlation of therapy response with other parameters in the radiotherapy treatment of head and neck neoplasms, considering the treatment setting, dosages, and techniques used
6 secondary outcomes
Acute toxicity
Time frame: immediate to 6 months after radiotherapy
Late toxicity
Time frame: from 6 months after radiotherapy, through study completion, an average of 1 year
Impact on the patient's quality of life
Time frame: From enrollment to the last follow-up at 12 months
Retreatments
Time frame: During the follow-ups, up to the last one at 12 months
Disease-free survival
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 at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
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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.
Alessio Giuseppe Morganti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Head and Neck Cancer, 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 2 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: looking for participants now, as of the sponsor's last update on 14 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 (+39 0516363136, alessio.morganti2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation of therapy response (time frame: From enrollment 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 14 Jan 2025.