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

NCT01806272 | Unknown Phase 2 DMC

• 1 other identifier: L-12-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nasopharyngeal Cancers

Keywords

rhGM-CSF; Oral Mucositis; Primary Nasopharyngeal Cancers; Chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• The incidence of grade II and less oral mucositis at the end of treatment

  Using the criteria of NCI CTCAE v3.0

  7 weeks

Secondary Outcomes (4)

• Pain

  12 weeks

• Cumulative incidence and time of grade III and more oral mucositis

  7 weeks

• Dysphagia

  12 weeks

• Tumor response to chemoradiotherapy

  12 weeks

Study Arms (2)

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.

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.

Drug: Compound Vitamin B12

Interventions

rhGM-CSF 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.

Also known as: 特尔立

Arm A

Compound Vitamin B12 DRUG

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

Also known as: 贯新克

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe uncontrolled infection.
• Pregnant or breast-feeding females.
• Allergy to this medicine.
• Diarrhea.

Sponsors & Collaborators

• Wei LUO: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Stomatitis

Interventions

regramostim

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Study Officials

• Wei LUO, M.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei LUO, M.D.

CONTACT

+862087343483; luowei2@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: March 7, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 29, 2013

Record last verified: 2013-03

Locations

CN (1)