Epithelial Tumor, MalignantNCT03183271
Proton Boost for Locally Advanced HEAD AND NECK TUMORS
A study testing external beam proton radiation therapy. in people with Epithelial Tumor, Malignant and Neuroendocrine Tumors, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial summary
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Epithelial Tumor, Malignant, Neuroendocrine Tumors
- What is being tested?
- external beam proton radiation therapy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jul 2012to 30 Sep 2016
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour
- Inoperable tumour, locally advanced stage
- Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx
- At least one lesion measured according to the RECIST criteria
- Enrollment for irradiation with IMRT up to 50-60 Gy RBE] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx.
Who cannot join
- Metastasis
- Previous radiotherapy
- Any metallic implants or other conditions such to prevent an adequate imaging of target volume
- Unavailability of previous IMRT first phase radiotherapy plans
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).
Read the detailed description
Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy [RBE] in 2-3 Gy [RBE] per fractions for 8-15 total fractions.
PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy [RBE].
Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.
- Conditions
- Epithelial Tumor, Malignant, Neuroendocrine Tumors
- Being tested
- external beam proton radiation therapy.
- Medical subject headings
- Carcinoma, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external beam proton radiation therapy.Radiation
Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: External beam radiotherapy | Experimental | A total of 20 patients will be irradiated with protons after photon IMRT Receives: Radiation: external beam proton radiation therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local response
RECIST criteria
Measured: 90 days
Acute toxicity
According to CTCAE v4.0
Measured: 90 days
Secondary outcomes (4)
Local control
RECIST criteria on MRI evaluation
Measured: 5 years
Disease free survival
RECIST criteria on MRI evaluation - months from RT treatment to documented local relapse
Measured: 5 years
Overall survival
On MRI and total body CT evaluation - months from RT treatment to death
Measured: 5 years
Late toxicity
According to CTCAE v4.0 registered during follow up visits
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 posted12 Jun 2017
- Study start16 Jul 2012
- Primary completion30 Mar 2015
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Tumor, MalignantStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183271
- Sponsor's protocol ID
- CNAO 06/2011
- Status last verified
- Jun 2017
- First submitted
- 4 Jun 2017
- Last updated
- 14 Jun 2017
- 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 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study on Proton Therapy Boost (Hadrontherapy) for Locally Advanced HEAD AND NECK TUMORS
- ClinicalTrials.gov ID
- NCT03183271
- Acronym / sponsor ID
- CNAO 06/2011
- Conditions
- Epithelial Tumor, Malignant, Neuroendocrine Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 16 Jul 2012 (actual)
- Primary completion
- 30 Mar 2015 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 12 Jun 2017 (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.
The aim of this research project is to test the local response and the acute toxicity (which can be observed within 90 days).
Detailed description
Local response and acute toxicity are primary endpoints of the trial. At CNAO a proton boost is delivered on the PTV1rx (area at high risk of relapse) up to at least 70 Gy [RBE] in 2-3 Gy [RBE] per fractions for 8-15 total fractions.
PTV2 rx (area at low or intermediate risk of relapse) will be irradiated with photon IMRT up to a total dose of 50-60 Gy [RBE].
Secondary endpoints of the trial are local control, relapse free survival, overall survival, tumor specific survival, intermediate and long term toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: External beam radiotherapy | Experimental | Radiation: external beam proton radiation therapy.A total of 20 patients will be irradiated with protons after photon IMRT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologic/cytologic diagnosis of primary epithelial malignant or neuroendocrine tumour
- Inoperable tumour, locally advanced stage
- Seated in rhinopharynx, nasal and paranasal sinuses, hypopharynx, larynx, oral cavity and oropharynx
- At least one lesion measured according to the RECIST criteria
- Enrollment for irradiation with IMRT up to 50-60 Gy RBE] on the PTV1rx and PTV2 rx to be followed at CNAO with irradiation with proton boost on thePTV1rx.
Key exclusion criteria (4 listed)
- Metastasis
- Previous radiotherapy
- Any metallic implants or other conditions such to prevent an adequate imaging of target volume
- Unavailability of previous IMRT first phase radiotherapy plans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| external beam proton radiation therapy.Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT. | Radiation | Experimental: External beam radiotherapy |
Primary outcome
Local response
Time frame: 90 days
RECIST criteria
Acute toxicity
Time frame: 90 days
According to CTCAE v4.0
4 secondary outcomes
Local control
Time frame: 5 years
Disease free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Late toxicity
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external beam proton radiation therapy. in people with Epithelial Tumor, Malignant and Neuroendocrine Tumors, run by CNAO National Center of Oncological Hadrontherapy 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jun 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local response (time frame: 90 days). 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 14 Jun 2017.