Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
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|ClinicalTrials.gov Identifier: NCT00964977|
Recruitment Status : Unknown
Verified November 2012 by Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz.
Recruitment status was: Recruiting
First Posted : August 25, 2009
Last Update Posted : November 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Cancer Oral Cancer Lymph Node Metastasis||Radiation: Radiation therapy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||560 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Adjuvant Radiotherapy in Patients With Oropharyngeal and Floor of Mouth Squamous Cell Carcinoma and Concomitant Histological Verification of Singular Ipsilateral Cervical Lymph Node Metastasis (pN1-state)|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2018|
No Intervention: no irradiation
Patients within this arm only receive curative intended radical surgery
Active Comparator: Radiation
Patients receive radiation within 6 weeks after curative intended radical surgery.
Radiation: Radiation therapy
Patients receive radiation within 6 weeks after surgery. At primary tumour site and involved lymph node level a total dose of 59.4 Gy in 33 fractions within 45 days is scheduled according to the rules of ICRU report 50.
- Primary study object: overall survival [ Time Frame: 9 years ]The objective of the clinical study will be to investigate two different patient groups (irradiated/unirradiated) with pT1/2 primary and verification of a singular ipsilateral lymph node metastasis in parallel design in order to evaluate the possible benefit of radiation therapy. The following null hypothesis forms the basis of the present study: Radiation therapy will have no influence on the overall survival in patients with pT1/2, pN1 primary tumor. First patients will be observed for 9 years, last patient in will be followed-up for 5 years.
- Time to occurrence of local relapse [ Time Frame: 2, 3 and 6 months; 1 year to 9 years ]Recruitment phase will be 4 years and follow up 5 years. First patients will be observed following the schedule above for 9 nine years, last patients will be observed for a minimum of 5 years.
- Time to lymphatic metastasis [ Time Frame: 2, 3 and 6 months, 1 year to 9 years ]Recruitment phase will be 4 years and follow up 5 years. First patients will be observed following the schedule above for 9 nine years, last patients will be observed for a minimum of 5 years.
- Time to occurence of distant metastasis [ Time Frame: 2,3,6 months and 1 year to 9 years annually ]Recruitment phase will be 4 years and follow up 5 years. First patients will be observed following the schedule above for 9 nine years, last patients will be observed for a minimum of 5 years.
- Quality of Life [ Time Frame: after 6 months, 1 year and annually till end of study ]QLQ 30 and HN35 Questionnaire will be assessed after 6 months and annually Course of provisional and definite orofacial rehabilitation will be assessed in each meeting
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964977
|Contact: Bilal Al-Nawas, MD,DMD,PHDfirstname.lastname@example.org|
|Contact: Maximilian Moergel, MD, DMDemail@example.com|
|Study Director:||Wilfried Wagner, MD, DMD, PHD|
|Principal Investigator:||Bilal Al-Nawas, MD, DMD, PHD|