Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.

NCT00964977 | Completed Phase 3 DMC

• 1 other identifier: DOESAK-pN1-108399
• Study Type: interventional
• Target: 209
• Locations: 3 countries
• Sites: 49

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 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.

Conditions

Oropharyngeal Cancer; Oral Cancer; Lymph Node Metastasis

Keywords

pN1; head and neck cancer; radiation; prognosis; comprehensive cohort design

Outcome Measures

Primary Outcomes (1)

• Primary study object: overall survival

  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.

  9 years

Secondary Outcomes (4)

• Time to occurrence of local relapse

  2, 3 and 6 months; 1 year to 9 years

• Time to lymphatic metastasis

  2, 3 and 6 months, 1 year to 9 years

• Time to occurence of distant metastasis

  2,3,6 months and 1 year to 9 years annually

• Quality of Life

  after 6 months, 1 year and annually till end of study

Study Arms (2)

no irradiation

NO INTERVENTION

Patients within this arm only receive curative intended radical surgery

Radiation

ACTIVE COMPARATOR

Patients receive radiation within 6 weeks after curative intended radical surgery.

Radiation: Radiation therapy

Interventions

Radiation therapy RADIATION

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.

Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Deutsche Krebshilfe e.V., Bonn (Germany): collaborator

Study Sites (49)

Universiätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

Location

Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

Location

Universitätsklinik München

München, Bavaria, Germany

Location

Universität Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Johann-Wolfgang Goethe-Universität

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinik Greifswald

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Universitätsklinikum Köln

Cologne, North Rhine-Westphalia, Germany

Location

Universitätsklinikum Dortmund

Dortmund, North Rhine-Westphalia, Germany

Location

Department of Oral and Maxillofacial Surgery,

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Otto von Guericke Universität Magdeburg

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Universitätsklinik Rostock

Rostock, Schleswig-Holstein, 18057, Germany

Location

Friedrich Schiller Universität Jena

Jena, Thuringia, 07740, Germany

Location

Universtiätsklinikum Aachen

Aachen, Germany

Location

Klinikum Augsburg

Augsburg, Germany

Location

Helios Kliniken Bad Saarow

Bad Saarow, Germany

Location

Charité Berlin

Berlin, Germany

Location

Universitätsklinikum Bonn

Bonn, Germany

Location

Klinikum Bremen-Mitte

Bremen, 28177, Germany

Location

Klinikum Bremerhaven

Bremerhaven, Germany

Location

Universitätsklinikum Dresden

Dresden, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Essen

Essen, Germany

Location

Klinikum Frankfurt Oder

Frankfurt (Oder), Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Klinikum Fulda

Fulda, Germany

Location

Marienhospital Gelsenkirchen

Gelsenkirchen, Germany

Location

Justus Liebig Universtität

Giessen, Germany

Location

Georg August Universitätsklinikum Göttingen

Göttingen, Germany

Location

Kreiskrankenhaus Gummersbach

Gummersbach, Germany

Location

Universitätsklinik Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Ruprecht-Karls-Universität Heidelberg

Heidelberg, Germany

Location

Universitätsklinikum Homburg/Saar

Homburg/Saar, Germany

Location

Universitätsklinikum Kiel

Kiel, Germany

Location

Bundeswehrkrankenhaus Koblenz

Koblenz, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Universitätsklinikum Schleswig-Holstein / Campus Lübeck

Lübeck, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Universitätsklinikum Marburg

Marburg, Germany

Location

Kliniken Maria Hilf Mönchengladbach

Mönchengladbach, Germany

Location

Universitätsklinikum Münster

Münster, Germany

Location

Brüderkrankenhaus St. Josef Paderborn

Paderborn, Germany

Location

Helios Kliniken Schwerin

Schwerin, Germany

Location

Klinikum Traunstein

Traunstein, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Helios Klinik Wuppertal

Wuppertal, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Universitätsklinikum Utrecht

Utrecht, Netherlands

Location

Universitätsspital Basel

Basel, Switzerland

Location

Related Publications (1)

• Moergel M, Jahn-Eimermacher A, Krummenauer F, Reichert TE, Wagner W, Wendt TG, Werner JA, Al-Nawas B. 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)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design. Trials. 2009 Dec 23;10:118. doi: 10.1186/1745-6215-10-118.

  PMID: 20028566 BACKGROUND

Related Links

• Homepage Deutsche Krebshilfe

MeSH Terms

Conditions

Oropharyngeal Neoplasms; Mouth Neoplasms; Lymphatic Metastasis; Head and Neck Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Neoplasms by Site; Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wilfried Wagner, MD, DMD, PHD

  STUDY DIRECTOR

• Bilal Al-Nawas, MD, DMD, PHD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr. Bilal Al-Nawas

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 25, 2022

Record last verified: 2022-02

Locations

CH (1); NL (1); DE (47)