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Recombinant Human Granulocyte Macrophage Colony Stimulating Factor(rhGM-CSF) Treating Oral Mucositis

NCT ID: NCT01806272

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-08-31

Brief Summary

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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

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Inclusion Criteria:

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
2. Receiving 68-72 Gray of radiation dose.
3. Age between 18 and 65 years.
4. KPS≥70.
5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria:

1. Severe uncontrolled infection.
2. Pregnant or breast-feeding females.
3. Allergy to this medicine.
4. Diarrhea.

Outcome measures:

1. Grade of oral mucositis:NCI Common Terminology Criteria for Adverse Events v3.0, NCI CTCAE v3.0
2. Pain: WHO,Numerical Rating Scale(NRS)
3. Tumor response to chemoradiotherapy:Response Evaluation Criteria in Solid Tumors,RECIST1.1

Conditions

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Nasopharyngeal Cancers

Keywords

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rhGM-CSF Oral Mucositis Primary Nasopharyngeal Cancers Chemoradiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

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.

Group Type EXPERIMENTAL

rhGM-CSF

Intervention Type DRUG

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

Intervention Type DRUG

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Arm B

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.

Group Type ACTIVE_COMPARATOR

Compound Vitamin B12

Intervention Type DRUG

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Interventions

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rhGM-CSF

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.

Intervention Type DRUG

Compound Vitamin B12

Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily

Intervention Type DRUG

Other Intervention Names

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特尔立 贯新克

Eligibility Criteria

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Inclusion Criteria

1. Grade II oral mucositis induced by chemoradiotherapy in patient with primary nasopharyngeal carcinoma.
2. Receiving 68-72 Gray of radiation dose.
3. Age between 18 and 65 years.
4. KPS≥70.
5. Patient who has given his/her written consent before any specific procedure of the protocol.

Exclusion Criteria

1. Severe uncontrolled infection.
2. Pregnant or breast-feeding females.
3. Allergy to this medicine.
4. Diarrhea.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wei LUO

OTHER

Sponsor Role lead

Responsible Party

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Wei LUO

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Wei LUO, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei LUO, M.D.

Role: CONTACT

Phone: +862087343483

Email: [email protected]

Facility Contacts

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Wei LUO, M.D.

Role: primary

Other Identifiers

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L-12-01

Identifier Type: -

Identifier Source: org_study_id