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

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 |
Arm | Intervention/treatment |
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No Intervention: no irradiation
Patients within this arm only receive curative intended radical surgery
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Active Comparator: Radiation
Patients receive radiation within 6 weeks after curative intended radical surgery.
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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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- 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

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

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

Study Director: | Wilfried Wagner, MD, DMD, PHD | ||
Principal Investigator: | Bilal Al-Nawas, MD, DMD, PHD |
Additional Information:
Publications:
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 Key Record Dates |
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 |