Status:
COMPLETED
Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
Lead Sponsor:
Johannes Gutenberg University Mainz
Collaborating Sponsors:
Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions:
Oropharyngeal Cancer
Oral Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Radiotherapy with or without adjuvant chemotherapy represents an important column of modern therapy in advanced squamous cell originated tumours of the head and neck. However to date no studies are av...
Detailed Description
Background Prevailing curative intended therapeutic strategies combine radical resection of the tumor mass with a safety margin followed by radiation of the original tumor site and adjacent locoregio...
Eligibility Criteria
Inclusion
- histological diagnosis of a primary squamous cell carcinoma of the oral cavity or the oropharynx
- maximum tumor diameter less than 4 cm in the pathohistological specimen irrespective of histological grading (pT1 or pT2)
- concomitant histological verification of a singular ipsilateral lymph node metastasis less than 3cm in diameter (pN1) without penetration of the lymph node´s capsule and without presence of invasion of lymphatic vessels (lymphangiosis carcinomatosa)
- radical resection of the tumor within adequate resection margins (R0)
- written informed consent from the patient
- adequate performance status ECOG Index ≤ 2
Exclusion
- an age less than 18 years old
- pregnant women
- reported drug addiction
- intake of remedies with potential influence on compliance or impaired judgment
- patients with mental disorders or conceivable physical, familial or job related embarrassments which may preclude the patient to realize the study schedule
- inadequate performance status ECOG Index \> 2
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
209 Patients enrolled
Trial Details
Trial ID
NCT00964977
Start Date
October 1 2009
End Date
December 1 2021
Last Update
February 25 2022
Active Locations (49)
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1
Universiätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
2
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
3
Universitätsklinik München
München, Bavaria, Germany
4
Universität Regensburg
Regensburg, Bavaria, Germany, 93053