Early Stage Glottic Squamous Cell Carcinoma With Poor DifferentiationNCT07781098
Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation
A study testing Radiation: intensity modulated radiotherapy (IMRT) in people with Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
There remains no uniform treatment modality for glottic laryngeal carcinoma. Current clinical guidelines broadly recommend surgery or radiotherapy as single-modality treatment for early-stage glottic laryngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation
- What is being tested?
- Radiation: intensity modulated radiotherapy (IMRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2026to 31 Dec 2031
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years, any gender
- Histologically proven glottic squamous cell carcinoma
- T1 T2N0M0 glottic laryngeal carcinoma with poor differentiation (moderate poor differentiation counted as poor differentiation)
- Subjects undergoing curative intent surgery must be enrolled 4 8 weeks after operation.
- No prior chemoradiotherapy or antineoplastic therapy
- ECOG PS 0 1
- Written informed consent provided
Who cannot join
- Moderately or well differentiated tumours
- Prior chemotherapy or other antineoplastic agents
- Prior head and neck irradiation
- Previous participation in another clinical trial
- Severe allergic history including contrast media allergy
- Pregnancy or lactation
Show all 9Show fewer
- Uncontrolled acute infection
- Drug/substance abuse, chronic heavy drinking, HIV infection
- Uncontrolled concomitant malignant disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital Of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation: A Prospective Multicenter Phase II Clinical Trial
There remains no uniform treatment modality for glottic laryngeal carcinoma. Current clinical guidelines broadly recommend surgery or radiotherapy as single-modality treatment for early-stage glottic laryngeal carcinoma. Surgery is the predominant treatment modality for patients with early-stage glottic carcinoma in China. Patients with poorly-differentiated early-stage glottic carcinoma exhibit inferior local control after surgery compared with those with moderately-to-well-differentiated tumours. Data from our previous retrospective study suggest that definitive radiotherapy/postoperative radiotherapy yields superior local control compared with surgery alone for poorly-differentiated early-stage glottic carcinoma. We hypothesize that definitive radiotherapy and postoperative radiotherapy can improve local control rates in patients with poorly-differentiated early-stage glottic squamous cell carcinoma. This study aims to conduct a multicenter, prospective, single-arm phase II clinical trial using intensity-modulated radiotherapy (IMRT) for patients with poorly-differentiated early-stage glottic laryngeal carcinoma, to preliminarily evaluate the impact of IMRT on local control rates and long-term survival outcomes in this patient population.
- Being tested
- Radiation: intensity modulated radiotherapy (IMRT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation: intensity modulated radiotherapy (IMRT)Radiation
Post operative radiotherapy (CTV): CTV1 is routine postoperative laryngeal target covering whole larynx, piriform sinus, glosso epiglottic vallecula, paraglottic space, pre epiglottic space, thyroid cartilage down to inferior border of cricoid cartilage. Given higher lymphatic metastatic risk of poorly differentiated tumours, CTV2 delineates bilateral cervical nodal levels II III. PTV1/PTV2 are 3 mm isotropic expansions of CTV1/CTV2. Prescription: PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions.
Definitive radiotherapy targets: Additional GTV denotes macroscopic tumour identified by laryngoscopy and imaging. PGTV/PTV1/PTV2 are 3 mm isotropic expansions of GTV/CTV1/CTV2. Prescription: PGTV 66 Gy/30 fractions; PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | intensity modulated radiotherapy (IMRT) Receives: Radiation: Radiation: intensity modulated radiotherapy (IMRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year local-regional failure-free survival (LRFS)
3-year local-regional failure-free survival (LRFS): defined as the time from the date of enrollment to recurrence of the primary lesion and perilesional tissues. The index date for recurrence is the date when a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of enrollment to the date of death. For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
Measured: From the date of enrollment to the date of local recurrence, , assessed up to 3 year.
Secondary outcomes (4)
5-year local-regional failure-free survival (LRFS)
5-year local-regional failure-free survival (LRFS): defined as the time from the date of enrollment to recurrence of the primary lesion and perilesional tissues. The index date for recurrence is the date when a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of enrollment to the date of death. For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
Measured: From the date of enrollment to the date of local recurrence, assessed up to 5 year.
5-year overall survival (OS)
Overall Survival(OS) is defined as the period from the date of enrollment to the date of death due to any cause.
Measured: From the date of enrollment until the date of death due to any cause, assessed up to 5 year.
5-year disease-free survival (DFS)
5-year disease-free survival (DFS): defined as the time from the date of enrollment during which the patient remains alive without evidence of tumour growth. Recurrence is defined as the emergence of new lesions, including recurrence of the primary lesion and perilesional tissues, cervical lymph-node metastasis, and distant metastasis. The index date for recurrence is the date on which a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, DFS is calculated from the date of enrollment to the date of death. For patients with no documented disease recurrence or death at the time of analysis (i.e., disease-free survivors), the time of the last efficacy assessment will serve as the endpoint.
Measured: Time from the date of enrollment to any evidence of tumour growth or death, assessed up to 5 year.
Adverse events
The incidence, type, and severity of adverse events (AEs), serious AEs, and immune-related AEs (irAEs) were assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version 5.0).
Measured: From enrollment to the end of treatment at 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start16 Sep 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Glottic Squamous Cell Carcinoma With Poor DifferentiationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781098
- Sponsor's protocol ID
- 2026-1250
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Radiotherapy in T1-T2N0M0 Glottic Carcinoma With Poor Differentiation: A Prospective Multicenter Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07781098
- Acronym / sponsor ID
- 2026-1250
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 24 Aug 2026 (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.
There remains no uniform treatment modality for glottic laryngeal carcinoma. Current clinical guidelines broadly recommend surgery or radiotherapy as single-modality treatment for early-stage glottic laryngeal carcinoma. Surgery is the predominant treatment modality for patients with early-stage glottic carcinoma in China. Patients with poorly-differentiated early-stage glottic carcinoma exhibit inferior local control after surgery compared with those with moderately-to-well-differentiated tumours. Data from our previous retrospective study suggest that definitive radiotherapy/postoperative radiotherapy yields superior local control compared with surgery alone for poorly-differentiated early-stage glottic carcinoma. We hypothesize that definitive radiotherapy and postoperative radiotherapy can improve local control rates in patients with poorly-differentiated early-stage glottic squamous cell carcinoma. This study aims to conduct a multicenter, prospective, single-arm phase II clinical trial using intensity-modulated radiotherapy (IMRT) for patients with poorly-differentiated early-stage glottic laryngeal carcinoma, to preliminarily evaluate the impact of IMRT on local control rates and long-term survival outcomes in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: Radiation: intensity modulated radiotherapy (IMRT)intensity modulated radiotherapy (IMRT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years, any gender
- Histologically proven glottic squamous cell carcinoma
- T1 T2N0M0 glottic laryngeal carcinoma with poor differentiation (moderate poor differentiation counted as poor differentiation)
- Subjects undergoing curative intent surgery must be enrolled 4 8 weeks after operation.
- No prior chemoradiotherapy or antineoplastic therapy
Key exclusion criteria (9 listed)
- Moderately or well differentiated tumours
- Prior chemotherapy or other antineoplastic agents
- Prior head and neck irradiation
- Previous participation in another clinical trial
- Severe allergic history including contrast media allergy
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 |
|---|---|---|
| Radiation: intensity modulated radiotherapy (IMRT)Post operative radiotherapy (CTV): CTV1 is routine postoperative laryngeal target covering whole larynx, piriform sinus, glosso epiglottic vallecula, paraglottic space, pre epiglottic space, thyroid cartilage down to inferior border of cricoid cartilage. Given higher lymphatic metastatic risk of poorly differentiated tumours, CTV2 delineates bilateral cervical nodal levels II III. PTV1/PTV2 are 3 mm isotropic expansions of CTV1/CTV2. Prescription: PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. Definitive radiotherapy targets: Additional GTV denotes macroscopic tumour identified by laryngoscopy and imaging. PGTV/PTV1/PTV2 are 3 mm isotropic expansions of GTV/CTV1/CTV2. Prescription: PGTV 66 Gy/30 fractions; PTV1 60 Gy/30 fractions; PTV2 54 Gy/30 fractions. | Radiation | Radiotherapy |
Primary outcome
3-year local-regional failure-free survival (LRFS)
Time frame: From the date of enrollment to the date of local recurrence, , assessed up to 3 year.
3-year local-regional failure-free survival (LRFS): defined as the time from the date of enrollment to recurrence of the primary lesion and perilesional tissues. The index date for recurrence is the date when a measurable new lesion is first identified. For patients who die of any other cause prior to documented disease recurrence, LRFS is calculated from the date of enrollment to the date of death. For patients without documented disease recurrence or death at the time of analysis (i.e., recurrence-free survivors), the time of the last efficacy assessment will be used as the endpoint.
4 secondary outcomes
5-year local-regional failure-free survival (LRFS)
Time frame: From the date of enrollment to the date of local recurrence, assessed up to 5 year.
5-year overall survival (OS)
Time frame: From the date of enrollment until the date of death due to any cause, assessed up to 5 year.
5-year disease-free survival (DFS)
Time frame: Time from the date of enrollment to any evidence of tumour growth or death, assessed up to 5 year.
Adverse events
Time frame: From enrollment to the end of treatment at 5 years.
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 24 Aug 2026.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: intensity modulated radiotherapy (IMRT) in people with Early Stage Glottic Squamous Cell Carcinoma With Poor Differentiation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 9 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 24 Aug 2026. 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?
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 Dongjun Dai, Doctor (86-0571-86992821, daidongjunmed@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year local-regional failure-free survival (LRFS) (time frame: From the date of enrollment to the date of local recurrence, , assessed up to 3 year.). 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 24 Aug 2026.