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 : 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|
Show Detailed Description
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964977
|Contact: Bilal Al-Nawas, MD,DMD,PHDemail@example.com|
|Contact: Maximilian Moergel, MD, DMDfirstname.lastname@example.org|
Show 49 Study Locations
|Study Director:||Wilfried Wagner, MD, DMD, PHD|
|Principal Investigator:||Bilal Al-Nawas, MD, DMD, PHD|