GM-CSFPhase 2NCT06472739
The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy
A Phase 2 study testing GM-CSF in people with GM-CSF, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- GM-CSF
- What is being tested?
- GM-CSF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 15 Nov 2024
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, world health organization [WHO] II or III).
- Original clinical staged as II-IVa (according to the 8 th AJCC edition) c. Male or female who are not pregnant. d. No evidence of distant metastasis (M0). e. Age between 18-65 years. f. WBC≥4×109/L, PLT≥100×109/L, HGB≥90g/L. g. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤ULN.
- With normal renal function test (creatinine clearance rate≥60 ml/min or creatinine< 1.5×ULN.
- The Eastern Cooperative Oncology Group (ECOG) Performance status less or equal to 1.
- Patients must be informed of the investigational nature of this study and give written informed consent.
- Patients receive induction chemotherapy plus concurrent chemoradiotherpy or concurrent chemoradiotherapy, or radiotherapy alone.
Who cannot join
- Age <18 or >65years. c. With clinical stage of I or IVb (according to the 8 th AJCC edition). d. Patients with tumor recurrence or distant metastasis. e. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
- History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
- Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
- Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
- Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and mental disturbance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Qiu-Yan Chen, Dr., 020-87343380, chenqy@sysucc.org.cn
About this study
Official title: The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial
To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.
Read the detailed description
Patients of GM-CSF group receive GM-CSF washmouth four times a day during radiotherapy. Control arm receive conventioanl care during radiotherapy. Visual signs of radiation or chemotherapy-induced mucosal damage were independently assessed during the course of RT by a radiation oncologist or other trained study personnel. The incidence of severe oral mucositis, the severe oral mucositis last time, quality of life between the two arms would be calculated.
- Conditions
- GM-CSF
- Being tested
- GM-CSF
- Keywords
- Nasopharyngeal Carcinoma, GM-CSF, oral mucositis
- Medical subject headings
- Nasopharyngeal Carcinoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
GM-CSF mouthwash four times per day at radiotherapy initiate, during the whole radiotherapy phase
| Study group | Role | What they receive |
|---|---|---|
| GM-CSF group | Experimental | Patients use GM-CSF mouthwash four times per day during radiotherpay. Receives: Drug: GM-CSF |
| Convertional care group | No intervention | Patients receive convertional care during radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of severe oral mucositis(grade 3+)
To evaluate the incidence of severe oral mucositis between the two arms.
Measured: During radiotherapy, up to 1.5 months.
Secondary outcomes (4)
Acute toxicities
The incidence rates of acute toxicities during treatment, evaluted by CTCAE Version5.0.
Measured: One month.
The last time of ≥3 grade oral mucositis
The time from first observed ≥3 grade oral mucositis to first observed oral mucositis decrease to less than grade 3
Measured: 1 months after radiotherapy
Daily questionaire of oral mucositis (OMDQ)
Patients are required to finish daily questionaire of oral mucositis by visual signs
Measured: 1 months after radiotherapy
Quality of life(QOL)
QOL is calculated by QLQ-C30.
Measured: 1 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start15 Sep 2023
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GM-CSFStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
- Investigators
- Qiu Yan Chen, Dr, Study chair, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472739
- Sponsor's protocol ID
- GM-CSF for OM
- Status last verified
- Jun 2024
- First submitted
- 30 Aug 2023
- Last updated
- 25 Jun 2024
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy: A Single-center, Phase II, Randomized Trial
- ClinicalTrials.gov ID
- NCT06472739
- Acronym / sponsor ID
- GM-CSF for OM
- Conditions
- GM-CSF
- Keywords
- Nasopharyngeal Carcinoma, GM-CSF, oral mucositis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 25 Jun 2024 (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.
To evaluate the efficacy of GM-CSF to preventing oral mucositis for patients with nasopharyngeal carcinoma receiving radiotherapy.
Detailed description
Patients of GM-CSF group receive GM-CSF washmouth four times a day during radiotherapy. Control arm receive conventioanl care during radiotherapy. Visual signs of radiation or chemotherapy-induced mucosal damage were independently assessed during the course of RT by a radiation oncologist or other trained study personnel. The incidence of severe oral mucositis, the severe oral mucositis last time, quality of life between the two arms would be calculated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GM-CSF group | Experimental | Drug: GM-CSFPatients use GM-CSF mouthwash four times per day during radiotherpay. |
| Convertional care group | No intervention | –Patients receive convertional care during radiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- a. Patients with histologically confirmed non-keratinizing nasopharyngeal carcinoma (including differentiated type and undifferentiated type, world health organization [WHO] II or III).
Key exclusion criteria (5 listed)
- Age <18 or >65years. c. With clinical stage of I or IVb (according to the 8 th AJCC edition). d. Patients with tumor recurrence or distant metastasis. e. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
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 |
|---|---|---|
| GM-CSFGM-CSF mouthwash four times per day at radiotherapy initiate, during the whole radiotherapy phase | Drug | GM-CSF group |
Primary outcome
The incidence of severe oral mucositis(grade 3+)
Time frame: During radiotherapy, up to 1.5 months.
To evaluate the incidence of severe oral mucositis between the two arms.
4 secondary outcomes
Acute toxicities
Time frame: One month.
The last time of ≥3 grade oral mucositis
Time frame: 1 months after radiotherapy
Daily questionaire of oral mucositis (OMDQ)
Time frame: 1 months after radiotherapy
Quality of life(QOL)
Time frame: 1 months after radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- 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.
Qiu Yan Chen, Dr study chair
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CSF in people with GM-CSF, run by Sun Yat-sen 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 6 inclusion and 5 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 25 Jun 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qiu Yan Chen, Dr (020-87343380, chenqy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of severe oral mucositis(grade 3+) (time frame: During radiotherapy, up to 1.5 months.). 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 25 Jun 2024.