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
18 Years
65 Years
Both
Nasopharyngeal Cancers
Trial Information
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
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
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The incidence of grade II and less oral mucositis at the end of treatment
Outcome Description:
Using the criteria of NCI CTCAE v3.0
Outcome Time Frame:
7 weeks
Safety Issue:
Yes
Principal Investigator
Wei LUO, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sun Yat-sen University
Authority:
China: Ethics Committee
Study ID:
L-12-01
NCT ID:
NCT01806272
Start Date:
March 2013
Completion Date:
August 2014
Related Keywords:
- Nasopharyngeal Cancers
- rhGM-CSF
- Oral Mucositis
- Primary Nasopharyngeal Cancers
- Chemoradiotherapy
- Stomatitis
- Nasopharyngeal Neoplasms
- Mucositis
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