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The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Daewoong Pharmaceutical Co. LTD..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01099891
First received: April 6, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted

April 6, 2010
April 6, 2010
March 2010
December 2011   (final data collection date for primary outcome measure)
Incidence of severe oral mucositis (RTOG garde 3 or 4) [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Incidence and duration of ≥ grade 2, 3 (RTOG scale) oral mucositis [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ] [ Designated as safety issue: No ]
  • Incidence and duration of ≥ grade 2, 3 (WHO scale) oral mucositis [ Time Frame: 5 weeks(at the point of receiving 50 Gy radiation) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Clinical Study for Evaluation of Efficacy and Safety of EGF on Oral Mucositis in Radiation Therapy Patients
Not Provided

The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy

Radiation therapy causes many side effects especially oral mucositis. The purpose of this Study is to evaluate the efficacy and safety of rhEGF on oral mucositis in patients receiving the radiation therapy or the concurrent chemo-radiotherapy. Head and neck cancer patients who have a plan to receive a minimum of 50 Gy radiation therapy will be enrolled.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stomatitis
  • Drug: rhEGF
    rhEGF 50 μg/ml, spray type, twice a day
  • Drug: Placebo
    Placebo, Spray type, Twice a day
  • Experimental: EGF
    Intervention: Drug: rhEGF
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, aged at least 18 years
  • Histologically confirmed diagnosis of head and neck cancer
  • Have a plan to receive at least 50 Gy radiation therapy
  • Have radiation sites included oral cavity and/or oropharynx
  • Performance status of 0 to 2 on the ECOG scale

Exclusion Criteria:

  • Females who are pregnant, nursing, or planning a pregnancy during the study period or females of childbearing potential
  • Known allergy or hypersensitivity to the study medication
  • Have head and neck tumors of the lips, salivary glands or unknown primary tumor
  • Have oral mucositis or other oral conditions at study entry
Both
18 Years and older
No
Contact: Sang-wook Lee, MD, PhD 82-11-9083-7574 lsw4435@gmail.co.kr
Korea, Republic of
 
NCT01099891
DW_EGF010P
Not Provided
Sang-wook, Lee, Asan medical center
Daewoong Pharmaceutical Co. LTD.
Not Provided
Not Provided
Daewoong Pharmaceutical Co. LTD.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP