Laryngeal NeoplasmsILALNCT04278638
IORT in Local Advanced Laryngocarcinoma
A study testing IORT, surgery and External radiotherapy in people with Laryngeal Neoplasms, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
The incidence of laryngeal cancer accounts for about 1 ~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Neoplasms
- What is being tested?
- IORT, surgery and External radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults over the age of 18;
- radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines);
- the expected survival time ≥ 3 months;
- sign informed consent for treatment and research with self-knowledge.
Who cannot join
- there is distant metastasis;
- pregnant women;
- patients with CT/MRI contraindications;
- the patient fails to receive treatment and/or follow-up as scheduled;
- bad fluid and organ function decompensation;
- multiple primary cancers;
- patients participating in other trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300000
Xinyuan Gong, +8613436640313, gxy0007@163.com
About this study
Official title: Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma
The incidence of laryngeal cancer accounts for about 1 ~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .
- Conditions
- Laryngeal Neoplasms
- Being tested
- IORT, surgery, External radiotherapy
- Medical subject headings
- Laryngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IORTRadiation
IORT in surgery of laryngocarcinoma
surgeryProcedure or surgery
total laryngectomy or hemilaryngectomy
External radiotherapyRadiation
External radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| with IORT | Experimental | Not described Receives: Radiation: IORT; Procedure: surgery; Radiation: External radiotherapy |
| without IORT | Active comparator | Not described Receives: Procedure: surgery; Radiation: External radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year local recurrence rate
In this study, no matter whether distant metastases occurred, if there was the presence of any anastomotic or lateral node recurrences, it was defined as local recurrence.
Criteria for local recurrence include (1) MRI results suggests local tumor recurrence, (2)Laryngoscopy indicates local tumor recurrence.
Measured: 2 year
Secondary outcomes (5)
2-year disease free survival
Compare 2-year disease free survival in patients with local advanced laryngocarcinoma treated with or without IORT.
Criteria for disease free survival means MRI and laryngoscopy (PET-CT if possible) indicate tumor free.
Measured: 2 years
2-year overall survival
Compare 2-year overall survival in patients with local advanced laryngocarcinoma treated with or without IORT.
Measured: 2 years
tissue necrosis
Compare the risk of tissue necrosis as determined visually by the Laryngoscope at 2 years after treatment in patients with local advanced laryngocarcinoma treated with or without IORT.
Measured: 2 years
fibrosis
Compare the risk of fibrosis as determined visually by the Laryngoscope at 2 years after treatment in patients with local advanced laryngocarcinoma treated with or without IORT.
Measured: 2 years
time of wound healing
Compare the time of wound healing after surgery in patients with local advanced laryngocarcinoma treated with or without IORT.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Jan 2018
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LiLi, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278638
- Sponsor's protocol ID
- 2019008
- Acronym
- ILAL
- Status last verified
- Oct 2020
- First submitted
- 16 Jan 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Li L, Zheng Y, Liu Q, Wei X, Gong X, Wang W, Lin P. A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol. BMC Cancer. 2020 Aug 6;20(1):734. doi: 10.1186/s12885-020-07233-1.
PubMed 32762662
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Safety and Feasibility With or Without Intraoperative Radiation in Local Advanced Laryngocarcinoma
- ClinicalTrials.gov ID
- NCT04278638
- Acronym / sponsor ID
- ILAL / 2019008
- Conditions
- Laryngeal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 20 Feb 2020 (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 incidence of laryngeal cancer accounts for about 1 ~ 5% of the total body tumors. For the surgical treatment of laryngeal cancer, the development trend of laryngocarcinoma treatment is to improve the local control rate, preserve the laryngeal function of patients as far as possible, and improve the life quality of patients. The efficacy, safety and feasibility of intraoperative radiotherapy (IORT) in head and neck cancer has been demonstrated in multiple institutional (3-5) studies to optimize local control. It is still unclear whether IORT can improve the local control and have efficacy, safety and feasibility in clinic. The purpose of this study was to observe the efficacy, safety and feasibility of IORT in local advanced laryngocarcinoma .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with IORT | Experimental | Radiation: IORT, Procedure: surgery, Radiation: External radiotherapy |
| without IORT | Active comparator | Procedure: surgery, Radiation: External radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults over the age of 18;
- radiographic or pathological diagnosis of local advanced laryngocarcinoma (according to NCCN guidelines);
- the expected survival time ≥ 3 months;
- sign informed consent for treatment and research with self-knowledge.
Key exclusion criteria (7 listed)
- there is distant metastasis;
- pregnant women;
- patients with CT/MRI contraindications;
- the patient fails to receive treatment and/or follow-up as scheduled;
- bad fluid and organ function decompensation;
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 |
|---|---|---|
| IORTIORT in surgery of laryngocarcinoma | Radiation | with IORT |
| surgerytotal laryngectomy or hemilaryngectomy | Procedure or surgery | with IORT, without IORT |
| External radiotherapyExternal radiotherapy | Radiation | with IORT, without IORT |
Primary outcome
2-year local recurrence rate
Time frame: 2 year
In this study, no matter whether distant metastases occurred, if there was the presence of any anastomotic or lateral node recurrences, it was defined as local recurrence. Criteria for local recurrence include (1) MRI results suggests local tumor recurrence, (2)Laryngoscopy indicates local tumor recurrence.
5 secondary outcomes
2-year disease free survival
Time frame: 2 years
2-year overall survival
Time frame: 2 years
tissue necrosis
Time frame: 2 years
fibrosis
Time frame: 2 years
time of wound healing
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 32762662Yang Y, Li L, Zheng Y, Liu Q, Wei X, Gong X, Wang W, Lin P. A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol. BMC Cancer. 2020 Aug 6;20(1):734. doi: 10.1186/s12885-020-07233-1.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IORT, surgery and External radiotherapy in people with Laryngeal Neoplasms, run by Tianjin First Central Hospital at 1 site in China.
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 4 inclusion and 7 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 23 Oct 2020. 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 China. 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 Xinyuan Gong (+8613436640313, gxy0007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year local recurrence rate (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278638, which also lists 1 linked publication.
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 23 Oct 2020.