Clinical Trials Logo
  1. Home
  2. Head and Neck Carcinoma
  3. NCT01228565
  4. Details
NCT01228565 Clinical Trial

Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

Head and Neck Carcinoma Clinical Trial

— GORTEC 2009-01  

Official title:
Placebo Controlled Randomized Trial of OTD70DERM® in Radio-dermatitis Induced by Radiotherapy-Erbitux®

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01228565
Other study ID # GORTEC 2009-01
Secondary ID
Status Completed
Phase Phase 3
First received October 25, 2010
Last updated March 23, 2015
Start date August 2010
Est. completion date May 2014

Study information
Verified date March 2015
Source Groupe Oncologie Radiotherapie Tete et Cou
Contact n/a
Is FDA regulated No
Health authority France : Agence Française de Securite Sanitaire des Produits de Sante (AFSSAPS)
Study type Interventional

Clinical Trial Summary

The aim of this randomized trial is to compare the rate of radio-dermatitis grade 2+ (NCI-CTC V3.0) in patients receiving radiotherapy+Erbitux+placebo versus in patients receiving radiotherapy+Erbitux+OTD70DERM® for the treatment of head and neck carcinoma.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Head and neck carcinoma treated by radiotherapy (70Gy) plus Erbitux

Exclusion Criteria:

- IMRT; Concomitant chemotherapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• Radiotherapy + Erbitux® + placebo
3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; Placebo local application, once a day, every day during the radiotherapy
• Radiotherapy+Erbitux+OTD70DERM
3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; OTD70DERM local application, once a day, every day during the radiotherapy

Locations
Country Name City State
France CHI Creteil Creteil
France Centre de Forcilles Ferolles Attily
France CLCC Nantes Nantes
France CHU Pitie Salpetriere Paris
France Institut Gustave Roussy Villejuif

Sponsors (1)
Lead Sponsor Collaborator
Groupe Oncologie Radiotherapie Tete et Cou

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radio-dermatitis grade 2, 3, 4 (NCI-CTC V3) Radio-dermatitis grade 2, 3, 4 (according to the NCI-CTC V3. Radio-dermatitis will be evaluated twice a week during radiotherapy and at M1, M2 and M3 after end of treatment. 3 months No
Secondary Quality of life Quality of life by the Dermatology Life Quality Index (DLQI) 3 months No
See also
  Status Clinical Trial Phase
Terminated NCT04110249 - Photoacoustic Imaging for Measuring Tumors and Normal Tissue in Patients With Head and Neck Cancer N/A
Not yet recruiting NCT06289049 - Heavy Strength Training in Head and Neck Cancer Survivors Phase 2
Completed NCT01831089 - Phase I Study of Lurbinectedin (PM01183) in Combination With Paclitaxel, With or Without Bevacizumab, in Selected Advanced Solid Tumors Phase 1
Completed NCT03663985 - FALCOn (Facteur AnthropoLogique Cancer Orl)
Recruiting NCT05544136 - A Study of Decreasing Radiation Therapy and Chemotherapy in People With Head and Neck Cancer Phase 2
Recruiting NCT05077072 - Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients Phase 2
Recruiting NCT04151082 - High Dose Steroid Therapy (Prednisone or Methylprednisolone) for the Improvement of Symptoms of Late Radiation-Associated Lower Cranial Neuropathy in Oropharyngeal Cancer Survivors Phase 1/Phase 2
Completed NCT03964896 - Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy N/A
Recruiting NCT04147494 - Experimental PET Imaging Scans Before Cancer Surgery to Study the Amount of PET Tracer Accumulated in Normal and Cancer Tissues Early Phase 1
Completed NCT02474095 - Acupuncture-Like Transcutaneous Electrical Nerve Stimulation in Treating Radiation-Induced Xerostomia in Patients With Head and Neck Cancer N/A
Withdrawn NCT03261180 - Nestle Impact Advanced Recovery in Improving Surgery Recovery in Patients With Head and Neck Cancer N/A
Terminated NCT04618432 - Collection of Clinical Data and Specimens for Research on Head and Neck and Communication Disorders
Active, not recruiting NCT02615275 - Bioelectrical Impedance Analysis in Estimating Body Composition in Patients With Stage I-IV Head and Neck Cancer Undergoing Radiation Therapy N/A
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Recruiting NCT00991094 - Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Recruiting NCT04870762 - Customized 3D Printed Oral Stents During Head and Neck Radiotherapy Phase 2
Completed NCT02369835 - Modified Dakin's Solution in Reducing Radiation-Induced Dermatitis in Patients With Head and Neck Cancer Undergoing Radiation Therapy Phase 3
Completed NCT03902535 - Geriatric and Quality of Life Assessments in Older Patients With Non-metastatic or Metastatic Head and Neck or Lung Cancer Undergoing Surgery or Chemoradiation and Their Caregivers
Recruiting NCT05526924 - Dosing Study of Radiation Combined With Tislelizumab and Pamiparib in Patients With Previously Treated Head and Neck Cancer Phase 1
Recruiting NCT03795610 - Window of Opportunity Study of IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma Phase 2

External Links