ORRNCT07449949
A Single-Arm Study on the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adult Nasal and Paranasal Sinus Rhabdomyosarcoma
An observational study of ORR and PFS, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
Given the rarity of nasal and paranasal sinus rhabdomyosarcoma (SNRMS), there is a lack of literature on systemic treatment models for adult SNRMS, let alone prospective clinical studies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- VMAT
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2025to 30 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 to 70 years
- All sexes
- Adult, Older adult
Study population: This study was conducted in patients with primary pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses without distant metastasis(subjects must have a measurable tumor lesion at baseline).
Who may be able to join
- Age: 18-70 years old, gender not limited.
- Pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses.
- First-time treatment patients.
- Distant metastasis was ruled out through a comprehensive physical examination.
- Cases that met the inclusion criteria after joint discussion with rhinologists.
- Expected survival period ≥6 months.
- ECOG score: 0-2.
Who cannot join
- Patients whose distant metastasis has been clearly identified.
- Previously, chemotherapy, immunotherapy or biological targeted therapy has been applied to the target lesion; Patients whose target lesions have received radiotherapy or surgery (excluding biopsy).
- Functional impairment of vital organs
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Arm Clinical Study Evaluating the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adults With Nasal and Paranasal Sinus Rhabdomyosarcoma
Given the rarity of nasal and paranasal sinus rhabdomyosarcoma (SNRMS), there is a lack of literature on systemic treatment models for adult SNRMS, let alone prospective clinical studies. After referring to the literature, combining clinical practice and summarizing the previous treatment data of our center, we plan to conduct a prospective clinical trial: a study on the treatment of adult SNRMS with induction chemotherapy combined with radical chemoradiotherapy followed by adjuvant chemotherapy and surgery. The cumulative chemotherapy course is 8 (4 courses before radiotherapy and 4 courses after radiotherapy), and the total radiotherapy dose is 62-66Gy.
- Being tested
- VMAT
- Keywords
- nasal and paranasal sinus rhabdomyosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VMATRadiation
Also called drug, Surgery
Vincristine: 1.4 mg/m², administered on the first day of each cycle. Actinomycin D: 1.5 mg/ m², intravenous injection, maximum not exceeding 2mg, administered on the first day of each cycle; Or epirubicin: 60-70 mg/m², intravenously infused for 30 minutes, administered on the first day of each cycle. Cisplatin: 25 mg/m², administered on days 1 to 3 of each cycle. Cyclophosphamide: 1-1.2 g/m², intravenously infused for 30-60 minutes, or 0.6-0.7 g/m², intravenously infused for 30-60 minutes; Administration on the first day of each cycle. Each administration cycle lasts for 3 weeks, with a total of 4+4 cycles. Local expanded field radiotherapy was performed within 2 weeks after the completion of 4 cycles of treatment, with the target area reaching a total dose of 62-66Gy. The specific dose was determined by the researcher based on the patient's specific condition. One month after completing radiotherapy, continue to complete four cycles of adjuvant chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
Measured: up to 24 weeks
Secondary outcomes (2)
PFS
progression free survival; It refers to the time between the start of treatment and the onset of disease progression or death from any cause
Measured: up to 5 year
OS
It refers to the time between the start of treatment and death from any cause. Patients alive at the last follow-up will be censored.
Measured: up to 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start30 Oct 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ORRStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449949
- Sponsor's protocol ID
- 2025206-1
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Clinical Study Evaluating the Efficacy of Sequential Chemoradiotherapy Followed by Surgery in Adults With Nasal and Paranasal Sinus Rhabdomyosarcoma
- ClinicalTrials.gov ID
- NCT07449949
- Acronym / sponsor ID
- 2025206-1
- Keywords
- nasal and paranasal sinus rhabdomyosarcoma
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 30 Oct 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 4 Mar 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.
Given the rarity of nasal and paranasal sinus rhabdomyosarcoma (SNRMS), there is a lack of literature on systemic treatment models for adult SNRMS, let alone prospective clinical studies. After referring to the literature, combining clinical practice and summarizing the previous treatment data of our center, we plan to conduct a prospective clinical trial: a study on the treatment of adult SNRMS with induction chemotherapy combined with radical chemoradiotherapy followed by adjuvant chemotherapy and surgery. The cumulative chemotherapy course is 8 (4 courses before radiotherapy and 4 courses after radiotherapy), and the total radiotherapy dose is 62-66Gy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study was conducted in patients with primary pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses without distant metastasis(subjects must have a measurable tumor lesion at baseline).
Key inclusion criteria (7 listed)
- Age: 18-70 years old, gender not limited.
- Pathologically confirmed as rhabdomyosarcoma of the nasal cavity and paranasal sinuses.
- First-time treatment patients.
- Distant metastasis was ruled out through a comprehensive physical examination.
- Cases that met the inclusion criteria after joint discussion with rhinologists.
Key exclusion criteria (3 listed)
- Patients whose distant metastasis has been clearly identified.
- Previously, chemotherapy, immunotherapy or biological targeted therapy has been applied to the target lesion; Patients whose target lesions have received radiotherapy or surgery (excluding biopsy).
- Functional impairment of vital organs
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 |
|---|---|---|
| VMATAlso: drug, SurgeryVincristine: 1.4 mg/m², administered on the first day of each cycle. Actinomycin D: 1.5 mg/ m², intravenous injection, maximum not exceeding 2mg, administered on the first day of each cycle; Or epirubicin: 60-70 mg/m², intravenously infused for 30 minutes, administered on the first day of each cycle. Cisplatin: 25 mg/m², administered on days 1 to 3 of each cycle. Cyclophosphamide: 1-1.2 g/m², intravenously infused for 30-60 minutes, or 0.6-0.7 g/m², intravenously infused for 30-60 minutes; Administration on the first day of each cycle. Each administration cycle lasts for 3 weeks, with a total of 4+4 cycles. Local expanded field radiotherapy was performed within 2 weeks after the completion of 4 cycles of treatment, with the target area reaching a total dose of 62-66Gy. The specific dose was determined by the researcher based on the patient's specific condition. One month after completing radiotherapy, continue to complete four cycles of adjuvant chemotherapy. | Radiation | – |
Primary outcome
ORR
Time frame: up to 24 weeks
Objective Response Rate; The proportion of patients who achieved pre-specified tumor volume reduction and maintained the minimum time frame required by accepted response evaluation criteria, such as Solid Tumor RECIST Version 1.1.
2 secondary outcomes
PFS
Time frame: up to 5 year
OS
Time frame: up to 5 year
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 4 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
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?
An observational study of ORR and PFS, run by Eye & ENT Hospital of Fudan University 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 3 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: enrolling by invitation, as of the sponsor's last update on 4 Mar 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?
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?
ORR (time frame: up to 24 weeks). 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 4 Mar 2026.