Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
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 available which study the effectiveness of radiotherapy in patients with resected small tumours (T1, T2) and concomitant ipsilateral metastasis of a single lymph node (pN1) for general treatment recommendation. The present study is designed as non-blinded, prospective, multicenter randomized controlled trial (RCT) for comparison of overall-survival as primary clinical target in patients receiving radiation therapy vs. patients without adjuvant radiation following curative intended surgery. Aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (radiation/non-radiation. Secondary clinical endpoints are as follows: Incidence and time to tumor relapse (locoregional relapse, lymph node involvement and metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module) and time from operation to orofacial rehabilitation.
Lymph Node Metastasis
Radiation: Radiation therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Primary study object: overall survival [ Time Frame: 9 years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00964977
|Contact: Bilal Al-Nawas, MD,DMD,PHDfirstname.lastname@example.org|
|Contact: Maximilian Moergel, MD, DMDemail@example.com|
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|Study Director:||Wilfried Wagner, MD, DMD, PHD|
|Principal Investigator:||Bilal Al-Nawas, MD, DMD, PHD|