Effectiveness of Adjuvant Radiotherapy in Small Oropharyngeal Squamous Cell Cancer and Single Lymph Node Metastasis.
This study is currently recruiting participants.
Verified November 2012 by Johannes Gutenberg University Mainz
Sponsor:
Johannes Gutenberg University Mainz
Collaborator:
Deutsche Krebshilfe e.V., Bonn (Germany)
Information provided by (Responsible Party):
Prof. Dr. Dr. Wilfried Wagner, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT00964977
First received: August 24, 2009
Last updated: November 15, 2012
Last verified: November 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Oropharyngeal Cancer Oral Cancer Lymph Node Metastasis |
Radiation: Radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| 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) |
Resource links provided by NLM:
Further study details as provided by Johannes Gutenberg University Mainz:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 560 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964977
Show 49 Study Locations
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 |
Show 49 Study LocationsSponsors 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
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 |
| Study First Received: | August 24, 2009 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Johannes Gutenberg University Mainz:
|
pN1 head and neck cancer radiation prognosis comprehensive cohort design |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Neoplasms, Squamous Cell Mouth Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Oropharyngeal Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Head and Neck Neoplasms Neoplasms by Site Mouth Diseases Stomatognathic Diseases Neoplastic Processes Pathologic Processes Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013