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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Oropharyngeal Cancer; Oral Cancer; Lymph Node Metastasis	Radiation: Radiation therapy	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	560 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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)
Study Start Date :	October 2009
Estimated Primary Completion Date :	December 2013
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Contacts and Locations

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Contacts

Contact: Bilal Al-Nawas, MD,DMD,PHD	0049-6131-173752	bilal.al-nawas@unimedizin-mainz.de
Contact: Maximilian Moergel, MD, DMD	0049-6131-175459	maximilian.moergel@unimedizin-mainz.de

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Sponsors and Collaborators

Johannes Gutenberg University Mainz

Deutsche Krebshilfe e.V., Bonn (Germany)

Investigators

Study Director:	Wilfried Wagner, MD, DMD, PHD
Principal Investigator:	Bilal Al-Nawas, MD, DMD, PHD

More Information

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Additional Information:

Homepage Deutsche Krebshilfe 

Publications:

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.

Responsible Party:	Prof. Dr. Dr. Wilfried Wagner, Prof. Dr. Dr. Wilfried Wager, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:	NCT00964977 History of Changes
Other Study ID Numbers:	DOESAK-pN1-108399
First Posted:	August 25, 2009
Last Update Posted:	November 16, 2012
Last Verified:	November 2012

Keywords provided by Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz:

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

Additional relevant MeSH terms:

Neoplasm Metastasis; Oropharyngeal Neoplasms; Mouth Neoplasms; Neoplastic Processes; Neoplasms; Pathologic Processes; Pharyngeal Neoplasms	Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases