Nasopharyngeal CancersPhase 2NCT01806272
Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis
A Phase 2 study testing rhGM-CSF and Compound Vitamin B12 in people with Nasopharyngeal Cancers, run by Wei LUO at 1 site in China.
Trial summary
This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasopharyngeal Cancers
- What is being tested?
- rhGM-CSF and Compound Vitamin B12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Mar 2013to Aug 2014
- 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
- Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
- Receiving 68-72 Gray of radiation dose.
- Age between 18 and 65 years.
- KPS≥70.
- Patient who has given his/her written consent before any specific procedure of the protocol.
Who cannot join
- Severe uncontrolled infection.
- Pregnant or breast-feeding females.
- Allergy to this medicine.
- Diarrhea.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Wei LUO, M.D., +862087343483, luowei2@mail.sysu.edu.cn
About this study
Official title: A Open,Randomized Phase II Trial Comparing Local Use of rhGM-CSF and Compound Vitamin B12 Solution to Compound Vitamin B12 Solution Alone Treating Chemoradiotherapy-induced Oral Mucositis in Patients With Primary Nasopharyngeal Carcinoma
This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II and less oral mucositis at the end of treatment.The hypothesis of the study is that the local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.
Read the detailed description
Inclusion Criteria:
- Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
- Receiving 68-72 Gray of radiation dose.
- Age between 18 and 65 years.
- KPS≥70.
- Patient who has given his/her written consent before any specific procedure of the protocol.
Exclusion Criteria:
- Severe uncontrolled infection.
- Pregnant or breast-feeding females.
- Allergy to this medicine.
- Diarrhea.
Outcome measures:
- Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0
- Pain: WHO,Numerical Rating Scale(NRS)
- Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1
- Conditions
- Nasopharyngeal Cancers
- Being tested
- rhGM-CSF, Compound Vitamin B12
- Keywords
- rhGM-CSF, Oral Mucositis, Primary Nasopharyngeal Cancers, Chemoradiotherapy
- Medical subject headings
- Nasopharyngeal Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGM-CSFDrug
Also called 特尔立
The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily.
Compound Vitamin B12Drug
Also called 贯新克
Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Local use of rhGM-CSF + Compound Vitamin B12 solution: The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily.
Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily
Radiotherapy: Intensity modulated radiation therapy(IMRT)
Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. Receives: Drug: rhGM-CSF; Drug: Compound Vitamin B12 |
| Arm B | Active comparator | Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily
Radiotherapy: Intensity modulated radiation therapy(IMRT)
Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. Receives: Drug: Compound Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of grade II and less oral mucositis at the end of treatment
Using the criteria of NCI CTCAE v3.0
Measured: 7 weeks
Secondary outcomes (4)
Pain
Cumulative incidence and time of different grade,using the criteria of WHO,NRS
Measured: 12 weeks
Cumulative incidence and time of grade III and more oral mucositis
Using the criteria of NCI CTCAE v3.0
Measured: 7 weeks
Dysphagia
Cumulative incidence and time of different grade,using NCI CTCAE v3.0
Measured: 12 weeks
Tumor response to chemoradiotherapy
Using the criteria of Response Evaluation Criteria in Solid Tumors1.1(RECIST1.1)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei LUO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei LUO, Sun Yat-sen University
- Investigators
- Wei LUO, M.D., Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806272
- Sponsor's protocol ID
- L-12-01
- Status last verified
- Mar 2013
- First submitted
- 4 Mar 2013
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open,Randomized Phase II Trial Comparing Local Use of rhGM-CSF and Compound Vitamin B12 Solution to Compound Vitamin B12 Solution Alone Treating Chemoradiotherapy-induced Oral Mucositis in Patients With Primary Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01806272
- Acronym / sponsor ID
- L-12-01
- Conditions
- Nasopharyngeal Cancers
- Keywords
- rhGM-CSF, Oral Mucositis, Primary Nasopharyngeal Cancers, Chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Wei LUOUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 7 Mar 2013 (estimated)
- 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.
This is a open,randomized phase II trial comparing effectiveness and safety of local use of rhGM-CSF and Compound Vitamin B12 to Compound Vitamin B12 solution alone treating oral mucositis in primary nasopharyngeal cancer. The main end point is the incidence of grade II and less oral mucositis at the end of treatment.The hypothesis of the study is that the local use of rhGM-CSF and Compound Vitamin B12 can decrease the incidence of grade III and more oral mucositis at the end of treatment compared to local use of Compound Vitamin B12 alone.
Detailed description
Inclusion Criteria:
- Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
- Receiving 68-72 Gray of radiation dose.
- Age between 18 and 65 years.
- KPS≥70.
- Patient who has given his/her written consent before any specific procedure of the protocol.
Exclusion Criteria:
- Severe uncontrolled infection.
- Pregnant or breast-feeding females.
- Allergy to this medicine.
- Diarrhea.
Outcome measures:
- Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0
- Pain: WHO,Numerical Rating Scale(NRS)
- Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: rhGM-CSF, Drug: Compound Vitamin B12Local use of rhGM-CSF + Compound Vitamin B12 solution: The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily. Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Radiotherapy: Intensity modulated radiation therapy(IMRT) Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. |
| Arm B | Active comparator | Drug: Compound Vitamin B12Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily Radiotherapy: Intensity modulated radiation therapy(IMRT) Chemotherapy:Docetaxel or cisplatin weekly or cisplatin once every three weeks during radiotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
- Receiving 68-72 Gray of radiation dose.
- Age between 18 and 65 years.
- KPS≥70.
- Patient who has given his/her written consent before any specific procedure of the protocol.
Key exclusion criteria (4 listed)
- Severe uncontrolled infection.
- Pregnant or breast-feeding females.
- Allergy to this medicine.
- Diarrhea.
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 |
|---|---|---|
| rhGM-CSFAlso: 特尔立The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily. | Drug | Arm A |
| Compound Vitamin B12Also: 贯新克Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily | Drug | Arm A, Arm B |
Primary outcome
The incidence of grade II and less oral mucositis at the end of treatment
Time frame: 7 weeks
Using the criteria of NCI CTCAE v3.0
4 secondary outcomes
Pain
Time frame: 12 weeks
Cumulative incidence and time of grade III and more oral mucositis
Time frame: 7 weeks
Dysphagia
Time frame: 12 weeks
Tumor response to chemoradiotherapy
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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.
Wei LUO, M.D. principal investigator
Sun Yat-Sen University Cancer Center
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 rhGM-CSF and Compound Vitamin B12 in people with Nasopharyngeal Cancers, run by Wei LUO 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 5 inclusion and 4 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 29 Mar 2013. 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 Wei LUO, M.D. (+862087343483, luowei2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of grade II and less oral mucositis at the end of treatment (time frame: 7 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 29 Mar 2013.