Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.


Clinical Trial Description

- To determine the 1-year rate of locoregional disease control in the experimental arm, using a control arm to avoid selection bias.

- To determine the 2 and 3 year rate of locoregional disease control.

- To evaluate the safety and toxicity of the combination of cetuximab and concomitant-boost accelerated radiotherapy followed by 12 weeks of complementary treatment with cetuximab. Both acute and chronic toxicity will be assessed.

- To determine specific disease-free survival, event-free survival, disease-specific survival and overall survival

- To determine acute and late toxicity

- To determine EGFR, p53, Ki67, and evaluate its value as a prognostic factor. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00251381
Study type Interventional
Source Trial Form Support S.L.
Contact Jaume Graupera
Phone 34 93 185 02 00
Email jaume.graupera@trialformsupport.com
Status Recruiting
Phase Phase 2
Start date November 2005
Completion date November 2009

See also
  Status Clinical Trial Phase
Completed NCT03239834 - Clinical Evaluation of the OncAlert RAPID in Subjects Presenting for Evaluation and/or Initial Biopsy; Impact on Decision-Making
Completed NCT03074110 - Isocapnic Hyperventilation - an Alternative Method N/A
Enrolling by invitation NCT04266093 - Gene Therapy Follow up Protocol for Subjects Previously Enrolled in NCI Center for Immuno-Oncology Studies
Recruiting NCT02792322 - Robotic Surgery in the Seated Position for Benign and Malignant Lesions of the Head and Neck N/A
Active, not recruiting NCT00918710 - Human Papillomavirus and Oropharynx Carcinoma N/A
Recruiting NCT05412628 - Investigating the Association Between Microbiota and Esophageal/Oropharyngeal Cancer N/A
Recruiting NCT04124198 - Quality of Life After Primary TORS vs IMRT for Patients With Early-stage Oropharyngeal Squamous Cell Carcinoma N/A
Completed NCT00721799 - F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients Phase 2
Recruiting NCT00181038 - Analgesia of Fibula Free Flap Donor Site by Peri-Neuronal Catheter in Oro-Pharyngeal Carcinoma Surgery Phase 3
Terminated NCT04015336 - E7 TCR Cell Induction Immunotherapy for Stage II and Stage III HPV-Associated Oropharyngeal Cancer Phase 2
Withdrawn NCT04044950 - A Phase II Study of Neoadjuvant E7 TCR T Cell Immunotherapy for Borderline Resectable and Unresectable Stage I HPV-Associated Oropharyngeal Cancer Phase 2
Completed NCT02262247 - A Post-Market Clinical Trial for Access and Visualization of the Oropharynx, Hypopharynx and Larynx During Transoral Procedures N/A
Terminated NCT01687413 - Post Operative Adjuvant Therapy De-intensification Trial for Human Papillomavirus-related, p16+ Oropharynx Cancer Phase 3
Completed NCT01530997 - De-intensification of Radiation & Chemotherapy in Low-Risk Human Papillomavirus-related Oropharyngeal Squamous Cell Ca Phase 2
Completed NCT03010813 - A Novel Robotic System for Single Port and Natural Orifice Transluminal Endoscopic Surgery N/A
Completed NCT03077243 - P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC Phase 2
Terminated NCT02045186 - Monitoring of Oral Human Papillomavirus Infection (HPV) in HPV-positive Oropharyngeal Squamous Cell Carcinoma (OPSCC) N/A
Withdrawn NCT02298595 - Cetuximab, Cisplatin and BYL719 for HPV-Associated Oropharyngeal Squamous Cell Carcinoma Phase 1/Phase 2
Active, not recruiting NCT02281955 - De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study Phase 2
Terminated NCT01525927 - Study of Chemotherapy Prior to Radiotherapy and Chemotherapy in Patients With HPV Associated Cancer of the Oral Cavity Phase 2