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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
  Purpose

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


Condition Intervention Phase
Stomatitis
 Drug: rhEGF
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: March 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EGF Drug: rhEGF
rhEGF 50 μg/ml, spray type, twice a day
Placebo Comparator: Placebo Drug: Placebo
Placebo, Spray type, Twice a day

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099891

Contacts
Contact: Sang-wook Lee, MD, PhD 82-11-9083-7574 lsw4435@gmail.co.kr

Locations
Korea, Republic of
Asan medical center Recruiting
Seoul, Korea, Republic of
Contact: Lee         lsw4435@gmail.co.kr    
Seoul National Colleage & Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hong-Gyun Wu, MD, PhD     82-2-2072-3177     wuhg@snu.ac.kr    
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
  More Information

No publications provided

Responsible Party: Sang-wook, Lee, Asan medical center
ClinicalTrials.gov Identifier: NCT01099891     History of Changes
Other Study ID Numbers: DW_EGF010P
Study First Received: April 6, 2010
Last Updated: April 6, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Stomatitis
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013