Radiotherapy-induced Nausea and Vomiting (RINV)Phase 4NCT07217600
Ondansetron Orodispersible Film for Vomiting Prevention in Pediatric Radiotherapy
A Phase 4 study testing Ondansetron orodispersible film once and Ondansetron orodispersible film twice in people with Radiotherapy-induced Nausea and Vomiting (RINV) and Pediatric Cancer, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused… Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Radiotherapy-induced Nausea and Vomiting (RINV), Pediatric Cancer
- What is being tested?
- Ondansetron orodispersible film once and Ondansetron orodispersible film twice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2025to Apr 2026
- Phase
- Phase 4
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with malignant tumors diagnosed by histopathology
- Age range: 1-14 years old (calculated from the day of signing the informed consent form)
- Weight >= 8Kg;
- Lansky functional status (LPS) score >= 50 (excluding posterior fossa syndrome)
- Be planned to undergo upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra
- Radiotherapy is administered once daily, and the fractional dose is 1.8Gy, except for 1.5 Gy for whole abdominal radiotherapy
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- The blood routine test must meet the following criteria: ANC >= 1.0 × 10^9/L (after discontinuation of G-CSF), PLT >= 50 × 10^9/L (without drug support or transfusion therapy), HGB >= 80g/L
- Biochemical tests must meet the following standards: total bilirubin <= 1.5 times ULN (upper limit of normal), ALT <= 2.5 times ULN, AST <= 2.5 times ULN, alkaline phosphatase ≤ 1.5 times ULN, serum albumin >= 2.5 g/dL, BUN and CRE <= 1.5 × ULN
- Expected survival period >= 3 months;
- The guardian of the child understands and signs the informed consent form, has good compliance, and cooperates with follow-up.
Who cannot join
- The nausea and vomiting caused by the surgery have not fully recovered if the subject has undergone a major surgery
- The patient has symptoms of central nervous system tumors such as cerebral edema and requires intervention with adrenal cortex hormones
- Participants who have participated in or are currently participating in other clinical studies within 4 weeks prior to the first use of the investigational drug (calculated based on the time of the last use of the investigational drug for those who have entered the follow-up period)
- Individuals allergic to 5-HT3 receptor antagonists or other excipients
- Joint use of apomorphine
- Congenital QT prolongation syndrome
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- Severe gastrointestinal obstruction
- Other observers who affect the efficacy and adverse reactions
- Used other 5-HT3 receptor antagonists in the first 3 days of enrollment
- According to the researchers' assessment, there may be other factors that could force the subjects to terminate the study midway, such as suffering from other serious illnesses (including mental illnesses) that require concurrent treatment, severe abnormal laboratory test values, family or social factors that may affect the safety of the subjects or the collection of experimental data.
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
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality
Yue Xie, +86 138 8308 0833, 344899525@qq.com
About this study
Official title: Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors
The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.
- Being tested
- Ondansetron orodispersible film once, Ondansetron orodispersible film twice
- Medical subject headings
- Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron orodispersible film onceDrug
Take ondansetron orodispersible film once 1-2 hours before each radiotherapy
Ondansetron orodispersible film twiceDrug
Take ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose.
| Study group | Role | What they receive |
|---|---|---|
| group QD | Experimental | Not described Receives: Drug: Ondansetron orodispersible film once |
| group BID | Active comparator | Not described Receives: Drug: Ondansetron orodispersible film twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Vomiting was divided into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Measured: From the first day of radiotherapy to 7 days after the end of radiotherapy
Secondary outcomes (2)
Adverse reaction rate
Measured: From the first day of radiotherapy to 7 days after the end of radiotherapy
The frequency of rescue treatments
Ratio of the number of rescue antiemetic uses to the number of radiotherapy fractions
Measured: From the first day of radiotherapy to 7 days after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start25 Mar 2025
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy-induced Nausea and Vomiting (RINV)Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yue Xie, Chongqing University Cancer Hospital
- Investigators
- Yue Xie, Principal investigator, Chongqing University Cancer Hospital, Chongqing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217600
- Sponsor's protocol ID
- CZLS2024304-A
- Other IDs
- ChiCTR2400093665
- Status last verified
- Oct 2025
- First submitted
- 30 Apr 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The initial data are available on request from the project leaders（344899525@qq.com），upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ondansetron Orodispersible Film in Preventing Vomiting Induced by Moderately Emetogenic Risk Radiotherapy in Pediatric Patients With Malignant Tumors
- ClinicalTrials.gov ID
- NCT07217600
- Acronym / sponsor ID
- CZLS2024304-A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 16 Oct 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.
The goal of this study is to evaluate the antiemetic efficacy and drug safety of ondansetron orodispersible film in pediatric patients with malignant tumors who received moderate emetic risk radiation induced vomiting, and to formulate reasonable and effective clinical medication regimen for preventing vomiting caused by moderate emetic risk radiation in children with malignant tumor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group QD | Experimental | Drug: Ondansetron orodispersible film once |
| group BID | Active comparator | Drug: Ondansetron orodispersible film twice |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children with malignant tumors diagnosed by histopathology
- Age range: 1-14 years old (calculated from the day of signing the informed consent form)
- Weight >= 8Kg;
- Lansky functional status (LPS) score >= 50 (excluding posterior fossa syndrome)
- Be planned to undergo upper abdominal or craniospinal radiation therapy, and the upper abdominal irradiation should cover the anatomical area from the upper edge of the 11th thoracic vertebra to the lower edge of the third lumbar vertebra
Key exclusion criteria (10 listed)
- The nausea and vomiting caused by the surgery have not fully recovered if the subject has undergone a major surgery
- The patient has symptoms of central nervous system tumors such as cerebral edema and requires intervention with adrenal cortex hormones
- Participants who have participated in or are currently participating in other clinical studies within 4 weeks prior to the first use of the investigational drug (calculated based on the time of the last use of the investigational drug for those who have entered the follow-up period)
- Individuals allergic to 5-HT3 receptor antagonists or other excipients
- Joint use of apomorphine
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 |
|---|---|---|
| Ondansetron orodispersible film onceTake ondansetron orodispersible film once 1-2 hours before each radiotherapy | Drug | group QD |
| Ondansetron orodispersible film twiceTake ondansetron orodispersible film once before each radiotherapy , and once again 8 hours after the first dose. | Drug | group BID |
Primary outcome
Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Time frame: From the first day of radiotherapy to 7 days after the end of radiotherapy
Vomiting was divided into 5 grades according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
2 secondary outcomes
Adverse reaction rate
Time frame: From the first day of radiotherapy to 7 days after the end of radiotherapy
The frequency of rescue treatments
Time frame: From the first day of radiotherapy to 7 days after the end of radiotherapy
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 20 Oct 2025.
- Individual participant dataSharing planned: Yes. The initial data are available on request from the project leaders（344899525@qq.com），upon reasonable request.
Related trials for Radiotherapy-induced Nausea and Vomiting (RINV)
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
Chemotherapy-Induced Nausea and Vomiting (CINV), Radiotherapy-induced Nausea and Vomiting (RINV)
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.
Yue Xie principal investigator
Chongqing University Cancer Hospital, Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron orodispersible film once and Ondansetron orodispersible film twice in people with Radiotherapy-induced Nausea and Vomiting (RINV) and Pediatric Cancer, run by Chongqing University Cancer 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 10 inclusion and 10 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 20 Oct 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yue Xie (+86 13883080833, 344899525@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy in preventing vomiting between the two groups, as per the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0 (time frame: From the first day of radiotherapy to 7 days after the end of radiotherapy). 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 20 Oct 2025.